Promus PREMIER™ H7493952824300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729844853), received between Mar 16, 2017 and May 15, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Bent” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTICED THAT THE TIP OF THE STENT SEEMED TO BE DAMAGED AND THE STRUTS WERE NOT IN PLACED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513847 ↗
• MalfunctionMay 9, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS IN THE LEFT CORONARY VESSEL. A 3.00X24MM PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500360 ↗
• MalfunctionDec 12, 2017Material Perforation; Device Damaged by Another Device; Material Perforation; Device Damaged by Another Device

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. AFTER A GUIDE WIRE CROSSED THE LESION, A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. THE GUIDE WIRE WAS INSERTED AT THE DISTAL END OF THE STENT. HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE EXITED DISTAL TO THE PROXIMAL WIRE LUMEN PORT AND THAT THE PHYSICIAN PERFORATED THE WIRE LUMEN OF THE STENT WITH THE GUIDE WIRE BEING USED. THE STENT WAS REMOVED WITH NO PATIENT HARM. A NEW 3.00X24MM PROMUS PREMIER¿ DES WAS USED ON THE SAME WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH GREAT PROGNOSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7110234 ↗
• MalfunctionNov 8, 2017Bent; Bent

  IT WAS REPORTED STENT DAMAGE OCCURRED. A 3.00X24 MM PROMUS PREMIER¿ STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, A BENT STENT STRUT WAS NOTED UPON LOADING THE DEVICE ONTO THE WIRE. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7009665 ↗
• MalfunctionAug 31, 2017Material Rupture; Material Rupture

  SAME CASE AS MDR ID# 2134265-2017-08692. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DISTAL TIP OF THE BALLOON RUPTURED AND THE STENT WAS NOT IMPLANTED. SUBSEQUENTLY, A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT A DIFFERENT VESSEL. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT APPEARED TO BE DAMAGED AND WAS NOT CRIMPED WELL ON THE BALLOON. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6833939 ↗
• InjuryApr 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON. A BALLOON CATHETER WAS THEN ADVANCED INTO THE STENT AND THE STENT WAS DEPLOYED WHERE IT WAS AND THE PROCEDURE WAS ENDED. LATER THAT EVENING, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND ANOTHER STENT WAS IMPLANTED IN THE INITIALLY INTENDED LOCATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457345 ↗
• MalfunctionMar 16, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. DURING UNPACKING, WHEN THE PHYSICIAN PULLED THE DEVICE ABOUT 2/3 OUT OF THE HOOP, IT WAS NOTICED THAT THE DEVICE HAD NO LESS THAN FIVE BENDS IN THE METAL TUBING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6409615 ↗