PROMUS Element™ Plus H7493911412220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729807759), received between Nov 28, 2016 and Aug 24, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 8.00 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 12 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. THE TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 90% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT WAS NOTED WITH MILD TO MODERATE RESTENOSIS AT THE OUTLET OF THE DISTAL LEFT ANTERIOR DESCENDING STUDY STENT. NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT.

  Patient problems: Reocclusion

  MAUDE report 7812525 ↗
• DeathNov 28, 2016Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  SAME CASED AS MDR ID: 2134265-2016-10605. PROMUS ELEMENT¿ PLUS CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00 MM. THE TARGET LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF 2.25 X 12 MM AND 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENTS WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Death; Thrombosis

  MAUDE report 6129840 ↗