Promus PREMIER™ H7493952838270Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729845010), received between Oct 17, 2017 and Jan 30, 2020 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJan 30, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS TO BE PERFORMED. DURING PREPARATION, THE PHYSICIAN TRIED LOADING THE 2.75 X 38MM PROMUS PREMIER DRUG-ELUTING STENT INTO THE WATCHDOG HEMOSTASIS VALVE AND IT CRUSHED THE STENT. THIS OCCURRED OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND THE ORIGINAL WATCHDOG WITHOUT FURTHER ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649091 ↗
• MalfunctionAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-JUL-2018. A 2.75X38MM PROMUS PREMIER¿ STENT WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7755332 ↗
• InjuryJan 8, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT THE IMPLANTED STENT WAS UNDERSIZED AND CHEST PAIN AND STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.75X38MM PROMUS PREMIER STENT WAS IMPLANTED AND POST-DILATED TO FINISH THE PROCEDURE. THE PATIENT LEFT THE CATH LAB. WITHIN TWO HOURS THE PATIENT HAD CHEST PAIN AND WAS BROUGHT BACK TO THE CATH LAB. THE STENT HAD THROMBOSED AND IT WAS NOTED THAT THE STENT WAS UNDERSIZED. THE STENT WAS DILATED WITH A 4.0 NON-COMPLIANT BALLOON AND A 4.0X24MM PROMUS PREMIER WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 7173553 ↗
• MalfunctionDec 21, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.50 X 20MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS LOADED OVER A NON-BSC GUIDE WIRE, IT WAS NOTED THAT THE DEVICE GOT STUCK ON THE WIRE AND WAS UNABLE TO BE REMOVED. THE DEVICES WERE REMOVED AS A UNIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139472 ↗
• MalfunctionOct 17, 2017Bent; Entrapment of Device; Bent; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.75X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED AND WHILE INTRODUCING THE STENT INTO THE SYSTEM IN THE TOUHY, DIFFICULTY TRACKING OVER A NON-BSC GUIDE WIRE WAS ENCOUNTERED. IT WAS NOTED THAT THE STENT WAS HUNG UP ON THE GUIDE WIRE AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT FURTHER. SUBSEQUENTLY, THE STENT AND THE GUIDE WIRE WERE DAMAGED AND WERE PULLED OUT. A NEW WIRE AND A NEW 2.75 X 38 SYNERGY DRUG-ELUTING STENT COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6955376 ↗