PROMUS Element™ Plus H7493911432250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729823681), received between Jan 17, 2017 and Mar 27, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-02409. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR EMERGENT CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE THIRD OBTUSE MARGINAL BRANCH (OM3) WITH 95% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE NOVO LONG LESION LOCATED FROM PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) TO DISTAL LCX WITH 100% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00 MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.25 X 28 MM PROMUS ELEMENT¿ PLUS STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS A DE NOVO LONG LESION LOCATED FROM PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) TO MID LAD WITH 100% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 X 32 MM AND 2.50 X 32 MM PROMUS ELEME

  Patient problems: Angina; Chest Pain; Dyspnea; High Blood Pressure/ Hypertension; Ischemia; Reocclusion

  MAUDE report 7373942 ↗
• InjuryMar 27, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-02408. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR EMERGENT CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE THIRD OBTUSE MARGINAL BRANCH (OM3) WITH 95% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE NOVO LONG LESION LOCATED FROM PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) TO DISTAL LCX WITH 100% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00 MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.25 X 28 MM PROMUS ELEMENT¿ PLUS STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS A DE NOVO LONG LESION LOCATED FROM PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) TO MID LAD WITH 100% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 X 32 MM AND 2.50 X 32 MM PROMUS ELEME

  Patient problems: Angina; Chest Pain; Dyspnea; High Blood Pressure/ Hypertension; Ischemia; Reocclusion

  MAUDE report 7373925 ↗
• InjuryJan 11, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS FURTHER REPORTED THAT THE SEVERE IN STENT RESTENOSIS OF THE RIGHT CORONARY ARTERY (RCA) HAS BEEN CONFIRMED TO CORRESPOND TO THE STUDY STENT DEPLOYED IN MID RCA AT THE TIME OF INDEX PROCEDURE. FUTURE INTERVENTION VIA LASER THERAPY OR ROTABLATOR IS PLANNED.

  Patient problems: Dyspnea; Reocclusion

  MAUDE report 7183415 ↗
• InjuryJan 17, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6). IT WAS REPORTED THAT STENT RESTENOSIS AND ANGINA OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS DIAGNOSED WITH MYOCARDIAL INFARCTION(MI). SUBSEQUENTLY, PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE SAME DAY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY(RCA) WITH 80% STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50MM. TARGET LESION # 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X32.00MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT(DES). FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL RCA WITH 80% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50MM. TARGET LESION # 2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50X12.00MM PROMUS ELEMENT PLUS DES. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. TWO DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% IN-STENT RESTENOSIS(ISR) LOCATED IN MID RCA WAS TREATED WITH BALLOON ANGIOPL

  Patient problems: Angina; Reocclusion

  MAUDE report 6255936 ↗