Promus PREMIER™ H7493952828350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844921), received between Nov 27, 2017 and Aug 21, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Bent” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50X28MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, AS THE DEVICE WAS ATTEMPTED TO BE INSERTED INTO THE PATIENT, THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802435 ↗
• MalfunctionFeb 21, 2018Break; Break

  SAME CASE AS MDR ID: 2134265-2018-01265. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50X28MM PROMUS PREMIER¿ STENT WAS SELECTED FOR USE. HOWEVER, UPON LOADING THE DEVICE OVER THE WIRE, THE STENT BROKE IN HALF. THE DEVICE WAS REPLACED WITH A 4.00X38MM PROMUS PREMIER¿ STENT BUT THE STENT WAS DAMAGED UPON TRYING TO INSERT THE DEVICE INTO THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286213 ↗
• MalfunctionDec 15, 2017Bent; Difficult to Remove; Bent; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, A 3.50X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A NON-BSC GUIDE EXTENSION CATHETER WAS USED. THE PHYSICIAN PUT THE STENT BACK THROUGH THE GUIDE EXTENSION CATHETER BUT IT WAS STILL UNABLE TO GO THROUGH. WHEN THE PHYSICIAN TRIED TO PULL THE STENT BACK, THE PROXIMAL END OF THE STENT GOT HUNG UP ON THE MOUTH OF THE EXTENSION CATHETER AND THE PHYSICIAN COULD NOT GET THE STENT TO RE-ENTER OR PULL THE STENT BACK THROUGH THE EXTENSION CATHETER. CONSEQUENTLY, THE PHYSICIAN HAD TO PULL OUT BOTH DEVICES ALL AT THE SAME TIME. WHEN THE DEVICES WERE REMOVED, IT WAS NOTED THAT THERE WERE SOME STRUTS FLARED OUT ON THE PROXIMAL END OF THE STENT THAT MADE IT CAUGHT ON THE GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120807 ↗
• MalfunctionNov 27, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50X28MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, UPON UNPACKING, THE MIDDLE PART OF THE STENT APPEARED BUCKLED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7059771 ↗