Promus PREMIER™ H7493952808250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729844594), received between Apr 11, 2017 and Oct 8, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS A RESTENOSIS OF A PREVIOUSLY IMPLANTED NON-BSC STENT IN THE CALCIFIED PROXIMAL CIRCUMFLEX ARTERY ONE MONTH AGO. THERE WAS A CHUNK OF CALCIUM PROXIMAL TO THE STENT. AFTER PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM NC EMERGE BALLOON CATHETER AT 20 ATMOSPHERES, A 2.50X8MM PROMUS PREMIER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN DECIDED TO PULL THE DEVICE OUT; HOWEVER, AFTER MULTIPLES ATTEMPTS TO GET THE DEVICE OUT, THE PHYSICIAN FELT A POP. UPON INSPECTION, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON AND WAS STUCK IN THE CALCIUM PROXIMAL TO THE LESION. A 2.5X12MM EMERGE BALLOON CATHETER WAS THEN ADVANCED AND USED TO DEPLOY THE STENT IN A NORMAL FASHION WITH EXCELLENT RESULTS. NO PATIENT COMPLICATIONS NOR BLOOD LOSS WERE REPORTED. THE DEVICE WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS ADVERSE EVENT RELATED TO PATIENT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944909 ↗
• MalfunctionApr 11, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 8 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE STENT APPEARED DEFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6481848 ↗