PROMUS Element™ Plus H7493911408250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807872), received between Apr 5, 2017 and Apr 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.

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

  (B)(6). IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 X 8 MM PROMUS ELEMENT¿ PLUS DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, PATIENT PRESENTED WITH INTERMITTENT CHEST PAIN SUGGESTIVE OF UNSTABLE ANGINA. THE CHEST PAIN WAS ASSOCIATED WITH SHORTNESS OF BREATH. SUBSEQUENTLY THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND WAS HOSPITALIZED ON THE SAME DAY. CORONARY ANGIOGRAPHY WAS PERFORMED AND AN 80% IN-STENT RESTENOSIS IN MID LAD WAS NOTED AND WAS THEN TREATED WITH PLACEMENT OF 3.00 X 20 MM SYNERGY¿ DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. ON THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Angina; Dyspnea; Reocclusion

  MAUDE report 6460860 ↗