Promus PREMIER™ H7493952838400Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729845041), received between Nov 15, 2016 and Jan 24, 2020 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE AND SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. A 4.00X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE SHAFT KINKED AND THE BALLOON WAS UNABLE TO INFLATE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628938 ↗
• MalfunctionJul 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.00X38MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN NOTICED THAT THE STENT WAS GETTING TO THE END OF THE GUIDE CATHETER, THE STENT GOT DISLODGED FROM THE BALLOON. THE PHYSICIAN STOPPED ADVANCING THE STENT AND STARTED TO PULL THE BALLOON AWAY FROM THE STENT. THE PHYSICIAN WENT BACK IN WITH A SMALLER 1.5 BALLOON AND IT WAS INSERTED THROUGH THE LUMEN OF THE STENT. THE BALLOON WAS INFLATED AND THE STENT WAS DRAWN BACK OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS ENDED AT THAT TIME AND DID NOT CONTINUE TO FIX THE RCA. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677067 ↗
• MalfunctionJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. A 4.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS RECEIVED WITH NO ISSUE REPORTED. HOWEVER, UPON REVIEW OF THIS DEVICE, MID-SHAFT BROKEN AND STENT DETACHMENT/SEPARATION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7596017 ↗
• InjuryMay 25, 2018Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED TIBIOPERONEAL TRUNK. A 4.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS CAUGHT ON A PREVIOUSLY IMPLANTED NON-BSC STENT AND WAS DISLODGED FROM THE DELIVERY SYSTEM. THE DISLODGED STENT WAS THEN POST DILATED IN THE POPLITEAL ARTERY AND 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 7544497 ↗
• MalfunctionFeb 21, 2018Bent; Bent

  SAME CASE AS MDR ID; 2134265-2018-01264. IT WAS REPORTED THAT STENT DAMAGE 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 7286217 ↗
• MalfunctionDec 8, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER THE DEPLOYMENT OF A 4.00X38MM PROMUS PREMIER¿ STENT, THE STENT DELIVERY SYSTEM (SDS) BROKE INSIDE THE GUIDE CATHETER. BOTH THE GUIDE AND SDS WERE REMOVED AS A UNIT. 8 FR MACH WAS USED AND WAS PLACED VIA THE FEMORAL TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100193 ↗
• InjuryNov 30, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00X38MM PROMUS PREMIER¿ STENT WAS DEPLOYED IN THE LESION. HOWEVER, UPON ATTEMPTING TO REMOVE THE DELIVERY BALLOON, IT BECAME STUCK AND THE SHAFT GOT BROKEN INSIDE THE PATIENT'S BODY. THE BROKEN PORTION WAS THEN RETRIEVED USING A SNARING DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072909 ↗
• MalfunctionOct 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00X38MM PROMUS PREMIER¿ STENT WAS ADVANCED THROUGH A GUIDEZILLA EXTENSION CATHETER TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO BE ADVANCED AND UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS PARTIALLY STRIPPED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6931436 ↗
• InjuryMay 3, 2017Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT BALLOON DEFLATION FAILED AND CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER CROSSING THE LESION WITH A NON-BSC GUIDE WIRE, A 4.00 X 38 MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS DEPLOYED. HOWEVER UPON BALLOON DEFLATION, THE BALLOON FAILED TO COLLAPSE PROPERLY AND THE CATHETER WAS HUNG UP ON THE GUIDE WIRE. THE ENTIRE SYSTEM WAS REMOVED AND A NEW GUIDE WIRE AND A BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540483 ↗
• MalfunctionDec 15, 2016Device Damaged Prior to Use; Activation, Positioning or Separation Problem; Device Damaged Prior to Use; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OF STENT OCCURRED. A 4.00X38MM PROMUS PREMIER¿ WAS SELECTED TO TREAT THE LESION. HOWEVER, UPON REMOVING THE DEVICE OUT OF THE BOX, IT WAS NOTED THAT THE STENT WAS UNWOUND ON THE WIRE AND EXPANDED. THE DEVICE WAS NOT INSERTED INTO THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6175367 ↗
• MalfunctionNov 15, 2016Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DAMAGE AND STENT MOVE ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00X38MM PROMUS PREMIER" DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENT. IT WAS THEN NOTED THAT THE STENT WAS DAMAGED AND PARTIALLY PULLED OFF FROM THE STENT DELIVERY SYSTEM. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104277 ↗
• MalfunctionNov 15, 2016Difficult to Remove; Difficult to Remove

  SAME CASE AS MDR ID: 2134265-2016-10215. IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SAPHENOUS VEIN. AFTER A 4.00X38MM PROMUS PREMIER¿ STENT WAS DEPLOYED, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON INTO THE GUIDE; HOWEVER, IT WAS NOTED THAT THE BALLOON WAS UNABLE TO REWRAP CORRECTLY AND THERE WAS A LOT OF WASTING. THE DEVICE GOT CAUGHT UP ON THE GUIDE AND HAD TO PULL THE WHOLE SYSTEM OUT. SUBSEQUENTLY, THE PHYSICIAN REWIRED THE ARTERY AND ATTEMPTED TO ADVANCE A 4.00 X 16 SYNERGY II DRUG-ELUTING STENT BUT FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENT. THERE WAS A LOT OF FORCE APPLIED AND WHEN THE PHYSICIAN TRIED TO RETRIEVE THE SYNERGY¿ STENT ALL THE WAY THROUGH UP TO THE GROIN, THE STENT GOT DISLODGED IN THE GROIN. THE PHYSICIAN WAS THEN ABLE TO RETRIEVE THE STENT THROUGH THE ARTERIOTOMY OF THE FEMORAL ARTERY WITH A HEMOSTATS AND A MINI CUT DOWN THAT WAS RIGHT AT THE MOUTH OF THE WHOLE ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6101405 ↗