Promus PREMIER™ H7493952832270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729844969), received between Mar 7, 2017 and Mar 7, 2017 — classified as 1 injury.

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.

• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR CASE # : 2134265-2017-01459 AND 2134265-2017-01570. IT WAS REPORTED THAT CHEST PAIN OCCURRED. IN (B)(6) 2017, 2 TARGET LESIONS WERE IDENTIFIED. THE TARGET LESION#1 WAS LOCATED IN THE SECOND OBTUSE MARGINAL. TARGET LESION#2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). THE 2000 UNITS OF HEPARIN WAS GIVEN. TARGET LESION#1 WAS THEN TREATED WITH 2.50 X 12 SYNERGY II DRUG-ELUTING STENT (DES) AND 2.25X12MM PROMUS PREMIER¿ DES. TARGET LESION#2 WAS TREATED WITH A 2.75X32MM PROMUS PREMIER¿ DES AND THE PROCEDURE WAS COMPLETED. THE FOLLOWING DAY, THE PATIENT PRESENTED DUE TO CHEST PAIN AND ELECTROCARDIOGRAM WAS PERFORMED. IT WAS THEN NOTED THAT THE PORTION OF THE SMALL CIRCUMFLEX ARTERY WAS OCCLUDED. 4000 UNITS OF HEPARIN WAS GIVEN AND A 2.25X15MM EMERGE BALLOON CATHETER WAS THEN ADVANCED AND DILATED THE OCCLUDED AREA FOR 6 INFLATIONS. THE PATIENT'S STATUS WAS STABLE AND THE PATIENT WAS THEN DISCHARGED.

  Patient problems: Chest Pain; Occlusion

  MAUDE report 6385571 ↗