Promus PREMIER™ H7493952832400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729844990), received between Dec 15, 2016 and Nov 16, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 4.00X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN A NON-BSC GUIDE EXTENSION CATHETER WAS USED, IT WAS NOTED THAT THE STENT BECAME LIFTED OFF THE PROXIMAL PORTION OF THE DELIVERY BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. A NEW STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077815 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE STENT FOUND DAMAGE TO THE DISTAL STENT ROWS 1, 3, 7 AND 9 WITH THE STENT STRUTS LIFTED SLIGHTLY. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND NOTED TO BE WITHIN SPECIFICATION. A VISUAL AND MICROSCOPIC EXAMINATION OF THE OF THE BUMPER TIP FOUND NO SIGNS OF DAMAGE. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND A BREAK IN THE HYPOTUBE 790MM DISTAL FROM THE DISTAL END OF THE STRAIN RELIED. MULTIPLE HYPOTUBE KINKS WERE ALSO NOTED ALONG THE FULL LENGTH OF THE CATHETER. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND MULTIPLE MIDSHAFT KINKS ALONG THE CATHETER. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851127 ↗
• MalfunctionApr 4, 2018Bent; Bent

  SAME CASE AS MDR ID: 2134265-2018-02449. 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 7396303 ↗
• MalfunctionOct 30, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, A 4.00X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING THE PROCEDURE, THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND THE DEVICE COULD NOT BE ADVANCED NOR COULD NOT BE REMOVED FROM THE GUIDEWIRE. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDEWIRE AND PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6987593 ↗
• MalfunctionMar 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-01716. IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.00X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT BUNCHED UP IN THE MIDDLE OF THE BALLOON AND SLID A COUPLE OF MILLIMETERS OFF THE END OF THE BALLOON. THE PROXIMAL END OF THE STENT WAS HALF WAY DOWN THE BALLOON. TO PREVENT THE STENT TO BE DISLODGED FROM THE BALLOON, THE PHYSICIAN DEPLOYED THE STENT TO WHERE IT WAS. THE PHYSICIAN THEN DILATED THE FIRST STENT AFTER IT WAS DEPLOYED. THE PHYSICIAN ADVANCED A 4.00X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT BUT THERE WAS DIFFICULTY PASSING THROUGH THE FIRST DEPLOYED STENT. WHILE PULLING THE SECOND STENT OUT, IT HUNG UP ON THE FIRST STENT AND THE FIRST STENT HUNG UP ON THE GUIDE. THE SECOND STENT HAD A BURR IN THE MIDDLE OF THE STENT. A NON-BSC GUIDE EXTENSION CATHETER WAS THEN ADVANCED AND ANOTHER PROMUS STENT WAS DELIVERED WHICH COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385270 ↗
• MalfunctionDec 20, 2016Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY. A 4.00X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND PRE DILATATION WAS DONE HOWEVER, THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED BY DILATING THE LESION WITH AN EMERGE BALLOON CATHETER AND IMPLANTATION OF A PROMUS STENT . NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188704 ↗
• MalfunctionDec 15, 2016Bent; Entrapment of Device; Bent; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2016-11862. IT WAS REPORTED THAT CATHETER ENTRAPMENT AND STENT DAMAGE OCCURRED. THE 100% CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. TWO 4.00X32MM PROMUS PREMIER STENTS AND A GUIDEZILLA WERE USED TO TREAT THE LESION. AS EACH 4.00X32MM PROMUS PREMIERSTENT WAS ADVANCED, THE DEVICE BECAME STUCK IN THE GUIDEZILLA. WHEN EACH DEVICE WAS REMOVED AS A UNIT, THE STENT STRUTS WERE NOTED TO BE FLARED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177986 ↗
• MalfunctionDec 15, 2016Bent; Entrapment of Device; Bent; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2016-11863. IT WAS REPORTED THAT CATHETER ENTRAPMENT AND STENT DAMAGE OCCURRED. THE 100% CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. TWO 4.00X32MM PROMUS PREMIER¿ STENTS AND A GUIDEZILLA¿ WERE USED TO TREAT THE LESION. AS EACH 4.00X32MM PROMUS PREMIER¿ STENT WAS ADVANCED, THE DEVICE BECAME STUCK IN THE GUIDEZILLA. WHEN EACH DEVICE WAS REMOVED AS A UNIT, THE STENT STRUTS WERE NOTED TO BE FLARED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177929 ↗