PROMUS Element™ Plus H7493911428350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729808046), received between Jan 5, 2017 and Jan 5, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2016-12409 (B)(6) STUDY. IT WAS REPORTED THAT IN STENT RESTENOSIS AND ANGINA OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS AN OSTIAL LESION LOCATED IN THE PROXIMAL PORTION OF SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM1) WITH 90% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION # 1 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 28 MM PROMUS ELEMENT¿ PLUS STENT, WITH 10% RESIDUAL STENOSIS. TARGET LESION # 2 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION # 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 12 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 3 WAS A DE NOVO LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 95% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION # 3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 28 MM PROMUS EL

  Patient problems: Angina; Reocclusion

  MAUDE report 6226044 ↗