PROMUS Element™ Plus H7493911412270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729807889), received between Sep 18, 2017 and Dec 21, 2017 — classified as 3 deaths.

The most frequently reported specific device problem is “Occlusion Within Device” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 21, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 98% STENOSIS. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.75X12MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS ALSO UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED OR NOT. IN (B)(6) 2017, THE SITE BECAME AWARE OF THE PATIENT'S DEATH DURING 5 YEAR FOLLOW-UP VIA PHONE CALL. THE PATIENT WAS NOT VISITED SINCE 2014; HOWEVER, SHE WAS LAST CONTACTED IN (B)(6) 2016 DURING 4 YEAR FOLLOW-UP. THE PATIENT¿S PHONE NUMBER WAS DISCONNECTED AND FURTHER CONTACT INFORMATION IS NOT AVAILABLE.

  Patient problems: Death; Thrombosis

  MAUDE report 7141028 ↗
• DeathOct 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROMUS ELEMENT PLUS STUDY. IT WAS REPORTED THAT ACUTE RESPIRATORY FAILURE OCCURRED AND THE PATIENT DIED. IN (B)(4) 2012, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 12 MM STUDY STENT AND RESIDUAL STENOSIS WAS 0 %. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017 THE SUBJECT PRESENTED TO THE HOSPITAL DUE TO ACUTE RESPIRATORY FAILURE AND WAS HOSPITALIZED ON THE SAME DAY. NINE DAYS LATER, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL AND DIED THE SAME DAY.

  Patient problems: Anemia; Cardiomyopathy; Congestive Heart Failure; Death; Respiratory Failure

  MAUDE report 6941785 ↗
• DeathSep 18, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. SAME CASE AS: 2134265-2017-09093 AND 2134265-2017-09094. IT WAS REPORTED THAT THE PATIENT EXPIRED. IN (B)(6) 2012 THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS PERFORMED AND THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION. TARGET LESION #1 WAS LOCATED IN THE 1ST DIAGONAL WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT USING 3.00 MM X 12.00 MM PROMUS ELEMENT¿ PLUS STENT, FOLLOWING POST DILATATION WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL LCX WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7MM. TARGET LESION #2 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 MM X 12.00 MM PROMUS ELEMENT¿ PLUS STENT FOLLOWING POST DILATATION WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS LOCATED IN THE DISTAL LCX WITH 60% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. TARGET LESION #3 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 16.00 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%

  Patient problems: Death; Thrombosis

  MAUDE report 6872494 ↗