Promus PREMIER™ H7493925216250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729828860), received between Jul 23, 2018 and Oct 12, 2023 — classified as 2 injuries.

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 18, 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.

• InjuryOct 12, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. CORONARY ANGIOGRAPHY REVEALED A BIFURCATED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80-90% DISEASE. THE TARGET LESION WAS DIRECTLY STENTED WITH A 16 X 2.50 PROMUS PREMIER DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS STABLE AND DISCHARGED ON DUAL ANTIPLATELET TREATMENT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH UNSTABLE ANGINA, EXPERIENCING LEFT-SIDED CHEST PAIN RADIATING INTO THE LEFT SHOULDER AND DOWN THE LEFT ARM FOR 2 DAYS. HEPARIN DRIP WAS STARTED, AND THE PATIENT WAS STABLE, AND THEIR PAIN WAS RESOLVED. THE PATIENT WAS DIAGNOSED WITH NON-ST-ELEVATION MYOCARDIAL INFRACTION AND HYPERTENSION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. ANGIOGRAPHY REVEALED 99% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED PROMUS PREMIER DRUG ELUTING STENT. FOLLOWING PRE-DILATION WITH A 2.00 X 12 EMERGE BALLOON, SUCCESSFUL ANGIOPLASTY WAS PERFORMED USING A 2.75 X 22 NON-BSC DRUG ELUTING STENT. FOLLOWING POST DILATION THERE WAS NO RESIDUAL STENOSIS. THE PATIENT BECAME SEVERELY NAUSEATED AND HYPERTENSIVE POSSIBLY DUE TO A CONTRAST ALLERGY AND WAS GIVEN

  Patient problems: Angina; High Blood Pressure/ Hypertension; Myocardial Infarction; Restenosis

  MAUDE report 17924951 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-07108, 2134265-2018-07109, 2134265-2018-07110. IT WAS REPORTED THAT PATIENT ¿CODED¿. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT ALSO HAD A CHRONIC TOTAL OCCLUSION IN THE RIGHT LAD AS WELL AS SIGNIFICANT DISEASE IN THE CIRCUMFLEX AND IN THE OBTUSE MARGINALS. THERE WERE A TOTAL OF 4 BSC STENTS DEPLOYED IN THE LAD AND ONLY ONE WAS EXPIRED WHICH WAS THE 16 X 2.50 PROMUS PREMIER¿ STENT. THE 3 OTHER STENTS WERE ONE PROMUS OTW AND 2 SYNERGY MR STENTS. THE EXPIRED STENT WAS DISCOVERED AFTER THE CASE, WHEN THE DEVICES USED WERE BEING CONSOLIDATED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FINE. HOWEVER, 3 DAYS POST-PROCEDURE, THE PATIENT CODED. A TEMPORARY PACEMAKER WAS IMPLANTED TO CONTROL THE PATIENT'S HEART RHYTHM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS RECOVERING.

  Patient problems: Cardiac Arrest

  MAUDE report 7710617 ↗