PROMUS Element™ Plus H7493911616350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807605), received between Jan 31, 2017 and Jan 31, 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 18, 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.

• InjuryJan 31, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND CORONARY ANGIOGRAPHY WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 16 MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN RADIATING TO THE JAW AND LEFT SIDE OF THE NECK AND RIGHT ARM. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. TWO DAYS LATER, CORONARY ANGIOGRAPHY WAS PERFORMED. THE 90% ISR IN THE MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 15 MM NON-BSC DRUG-ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: Chest Pain; Reocclusion

  MAUDE report 6289411 ↗