PROMUS Element™ Plus H7493911616250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807360), received between Apr 9, 2018 and Apr 9, 2018 — 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 9, 2018Occlusion Within Device; Occlusion Within Device

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CHEST DISCOMFORT AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH SILENT ISCHEMIA AND WAS DIAGNOSED WITH STABLE ANGINA. THE SUBJECT WAS THEN REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH PROGRESSIVE ACCELERATING EXERTIONAL CHEST DISCOMFORT. SUBSEQUENTLY, THE SUBJECT WAS HOSPITALIZED AND CORONARY ANGIOGRAPHY WAS PERMED WHICH REVEALED AN 80% IN-STENT RESTENOSIS (ISR) OF THE PREVIOUSLY IMPLANTED 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT IN DISTAL LCX. THE STRESS TEST PERFORMED ON THE SAME DAY REVEALED DISTAL, ANTERIOR, APICAL AND POSTEROLATERAL LATERAL WALL ISCHEMIA. THE SUBJECT WAS HOSPITALIZED AND REFERRED FOR CARDIAC CATHETERIZATI

  Patient problems: Angina; Chest Pain; Reocclusion

  MAUDE report 7409162 ↗