Absorbable Coronary Drug-Eluting Stent
FDA adverse event reports and recall history for absorbable coronary drug-eluting stent (product code PNY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 929
- Deaths
- 110
- Injuries
- 784
- Malfunctions
- 35
Reports per year
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-06-01TerminatedOther
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
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