Promus PREMIER™ H7493952812400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729844693), received between Jan 26, 2017 and Apr 18, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2018Bent; Break; Bent; Break

  IT WAS REPORTED THAT STENT DAMAGE AND SHAFT BREAK OCCURRED. A 4.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT STENT WAS DAMAGED AND THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441281 ↗
• MalfunctionApr 4, 2018Bent; Bent

  SAME CASE AS MDR ID 2134265-2018-02450. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER A 6F JR4 RUNWAY GUIDE CATHETER WAS IN PLACE, A 4.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT IT WAS NOTED THAT THE STENT GOT CAUGHT WITH THE GUIDE CATHETER AND WAS DAMAGED. THE DEVICE WAS REMOVED AND A 4.00X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN ADVANCED; HOWEVER, THE STENT GOT CAUGHT WITH THE GUIDE CATHETER AND THE PHYSICIAN FELT THAT THE SECOND STENT WAS DAMAGED AS WELL. THE GUIDE CATHETER WAS PULLED OUT AND A NEW GUIDE CATHETER WAS THEN UTILIZE TO SUCCESSFULLY DEPLOY THE STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396293 ↗
• MalfunctionFeb 22, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION; HOWEVER, AS THE DEVICE WAS LOADED OVER THE WIRE, THE WIRE DID NOT EXIT AT THE WIRE PORT, INSTEAD PUNCTURED THROUGH THE SHAFT OF THE STENT. THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290732 ↗
• MalfunctionDec 13, 2017Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER CROSSING A WIRE TO THE LESION, A 4.00X12MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT BECAME STUCK WITH THE WIRE AT ABOUT 10 CM PROXIMAL TO THE GUIDE CATHETER. THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER IT WOULD NOT COME OFF THE WIRE. MOREOVER, THE SHAFT GOT SEPARATED 10-15 CM FROM THE HUB UPON PULLING THE DEVICE REALLY HARD. SUBSEQUENTLY, BOTH THE PROMUS STENT AND THE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116278 ↗
• MalfunctionJan 26, 2017Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT SHAFT BREAK AND CATHETER ENTRAPMENT OUTSIDE PATIENT OCCURRED. AFTER PLACING A NON-BSC GUIDE WIRE, A 4.00X12 MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING OVER THE NON-BSC GUIDE WIRE WHILE STILL OUTSIDE THE PATIENT'S BODY, THE DEVICE GOT STUCK AND COULD NOT COME OFF. AFTER SEVERAL ATTEMPTS OF PULLING THE DEVICE OFF THE WIRE, IT WAS NOTED THAT THE SHAFT HAD FRACTURED APPROXIMATELY 20 MM DISTAL TO THE RX PORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6280981 ↗