Promus PREMIER™ H7493952820250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844778), received between Dec 6, 2016 and Jul 3, 2018 — classified as 2 injuries, 2 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 18, 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.

• MalfunctionJul 3, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER A NON-BSC GUIDE CATHETER WAS ENGAGED, A 2.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON DRAWING BACK THE STENT INTO THE GUIDE CATHETER, THE DEVICE BECAME STUCK AND IT WAS NOTED THAT A SMALL SEGMENT HUNG UP ON THE DISTAL OPENING. BOTH DEVICES WERE COMPLETELY REMOVED WITHOUT ADVERSE EFFECT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE AND A 2.5X22MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658817 ↗
• MalfunctionApr 27, 2018Bent; Bent

  SAME CASE AS MDR ID: 2134265-2018-03606 AND 2134265-2018-03607. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY TORTUOUS AND HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED, THEN A 2.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED, BUT ALSO FAILED TO CROSS THE LESION AND WAS DAMAGED. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN IMPLANTED IN LAD, THEN A 2.50 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED DISTAL TO THE LESION. BUT WHEN THE STENT WAS DEPLOYED, THE BALLOON RUPTURED AND BECAME STUCK ON EITHER THE CALCIUM OR THE STENT STRUTS AND THE BALLOON CATHETER WAS DIFFICULT TO REMOVE. EVENTUALLY, THE BALLOON CATHETER WAS REMOVED AND THE STENT WAS IMPLANTED. HOWEVER, WHEN THE PATIENT WAS SOMEWHAT STABILIZED, IT WAS NOTED THAT THE LAD HAD ACTUALLY DISSECTED DISTAL TO THE STENT. IT WAS THEN DECIDED TO SEND THE PATIENT FOR SURGERY DUE TO THE DISTAL DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S POST-SURGICAL CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7469110 ↗
• InjuryMar 14, 2017Fracture; Fracture

  IT WAS REPORTED THAT PLAQUE SHIFT AND STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT IN THE OBTUSE MARGINAL BRANCH. AFTER A .075 NON-BSC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.50X23MM STENT WAS DEPLOYED TO COVER THE PROXIMAL LESION THAT EXTENDED TO THE OSTIUM. THE DISTAL LESION WAS THEN PRE-DILATED WITH A 2.0X15MM NON-COMPLIANT BALLOON CATHETER AND A 2.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS DEPLOYED WHERE THERE WAS IN-STENT RESTENOSIS IN A PREVIOUSLY IMPLANTED STENT. HOWEVER, THE PHYSICIAN NOTED SOME PLAQUE SHIFT PROXIMAL TO THE STENT, SO A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS DEPLOYED TO OVERLAP THE 2.50X20MM PROMUS PREMIER¿ STENT. SUBSEQUENTLY, THE TWO PROMUS PREMIER¿ STENTS WERE POST-DILATED WITH A 3.0X15MM NON-COMPLIANT BALLOON CATHETER AND THE PROXIMAL OSTIAL STENT WAS POST-DILATED WITH A 3.0X20MM AND 3.50X12MM NON-COMPLIANT BALLOON CATHETERS WITH GOOD RESULTS. AFTER POST-DILATATION, THE PHYSICIAN NOTED AN ACUTE STENT FRACTURE OF THE 2.50X20MM PROMUS PREMIER¿ STENT. THE PHYSICIAN ATTEMPTED TO STENT JAIL THE SEGMENT WITH A 2.50X18MM NON-BSC STENT BUT IT WAS UNABLE TO CROSS THE LESION. THE

  Patient problems: Obstruction/Occlusion

  MAUDE report 6404405 ↗
• InjuryDec 6, 2016Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED.  A 2.50X20MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON WITHDRAWAL OF THE DEVICE, THE STENT DISLODGED AND A SNARE WAS USED TO RETRIEVE THE STENT. IT WAS THEN NOTED THAT THE STENT WAS STRETCHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149445 ↗