A Word of Caution | Zendy

Petros S. Dardas | Zendy; Vasilis Thanopoulos | Zendy; Efstratios K. Theofilogiannakos | Zendy; Vlasis Ninios | Zendy; Alexandros Kallifatidis | Zendy; Antoniοs Pitsis | Zendy

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A Word of Caution

Author(s) -

Petros S. Dardas,

Vasilis Thanopoulos,

Efstratios K. Theofilogiannakos,

Vlasis Ninios,

Alexandros Kallifatidis,

Antoniοs Pitsis

Publication year - 2014

Publication title -

circulation

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 7.795

H-Index - 607

eISSN - 1524-4539

pISSN - 0009-7322

DOI - 10.1161/circulationaha.113.007877

Subject(s) - medicine , word (group theory) , linguistics , intensive care medicine , philosophy

The US Food and Drug Administration has alerted providers and patients that the catheter-delivered Amplatzer atrial septal occluder (AGA Medical, Golden Valley, MN) from St. Jude Medical poses a small risk of potentially life-threatening complications.1 According to the agency, the device can erode the surrounding tissue over time and may cause cardiac tamponade or other complications that require immediate surgery. The agency estimates the risk of such emergencies at 1 to 3 per 1000 implanted patients and notes that >230 000 Amplatzer atrial septal occluder devices have been implanted around the world. The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the …

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