FDA Reports Serious Erosion Events With Amplatzer Septal ... | 合法醫療器材資訊網

The U.S. Food and Drug Administration (FDA) issued a warning this week about safety issues encountered with the St. Jude Amplatzer Atrial Septal Occluder (ASO). The transcatheter device is used to seal congenital holes in the atrial septum. The FDA reported in a rare safety communication that the device may cause life-threatening tissue erosion inside the heart.

Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the Amplatzer ASO. During the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device. The FDA said these cases resulted in life-threatening emergencies that required immediate surgery.

The device is made of a self-expanding nitinol metal mesh, which if the device is sized improperly, will rub against the wall of the heart a...

FDA Reports Serious Erosion Events With Amplatzer Septal ... | 合法醫療器材資訊網

Amplatzer patent foramen ovale occluder | 合法醫療器材資訊網

由 R Madhkour 著作 · 2019 · 被引用 12 次 — The patent foramen ovale (PFO) is a common anatomical variant in ... Amplatzer patent foramen ovale occluder: safety and efficacy ... Patent / surgery*; Humans; Septal Occluder Device / adverse effects*; Treatment Ou Read More

Long | 合法醫療器材資訊網

由 NC Suligoj 著作 · 2020 · 被引用 1 次 — BioSTAR provided similar PFO closure rate as Amplatzer PFO occluder. ... echocardiography after patent foramen ovale closure by BioSTAR and Amplatzer patent ... 0%; p = .08), there was no adverse events. ... Absorbabl Read More

Closure of patent foramen ovale | 合法醫療器材資訊網

由 B Meier 著作 · 2005 · 被引用 134 次 — The 35 mm Amplatzer PFO occluder is destined for large PFOs with an ... The pusher cable is derived from a biotome gripping a ball tip at the right side end of the axis. ... Effect on migraine of closure of cardiac rig Read More

Embolization of Patent Foramen Ovale Closure Devices | 合法醫療器材資訊網

由 SS Goel 著作 · 2013 · 被引用 14 次 — Two 11F femoral vein sheaths were placed, one on each side. ... Then a 35-mm AMPLATZER PFO Occluder was successfully deployed across the ... the Amplatzer PFO occluder without intraprocedural echocardiography: effect of Read More

Long | 合法醫療器材資訊網

由 A Araszkiewicz 著作 · 2016 · 被引用 6 次 — The device (Amplatzer PFO Occluder, St. Jude Medical, USA) was ... “Migraine side effect” and stroke recurrence in late follow-up after ... Read More

Amplatzer PFO Occluder | 合法醫療器材資訊網

由 HFAN EXPERT 著作 — Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic ... Read More

AMPLATZER™ PFO Occluder Patient Information Guide | 合法醫療器材資訊網

Weakness or numbness of the face, arm or leg, especially on one side of the body ... An AMPLATZER PFO Occluder is a device specifically designed to stop blood ... Although most medical equipment will have no effect on your device it is best ... Read More

Late erosion of an Amplatzer septal occluder device 6 years ... | 合法醫療器材資訊網

由 NW Taggart 著作 · 2011 · 被引用 54 次 — Amplatzer septal occluder device (AGA Medical Corpora- tion, Golden ... erosion of Amplatzer ASD and PFO occluder devices is esti- ... ration of the left side of the disk through the dome of the left ... monly though Read More

Serum Nickel and Titanium Levels after Transcatheter Closure ... | 合法醫療器材資訊網

由 O Elkiran 著作 · 被引用 3 次 — Systemic side effects associated with nickel allergy, pericarditis, and ... The Amplatzer septal occluder is composed of nitinol (Ni amount 54.5–57.0 wt. ... occluder was used for transcatheter closure of ASD and patent forame Read More

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