Promus PREMIER™ H7493952820400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844815), received between May 3, 2017 and Apr 17, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. AFTER DEPLOYING A 4.00X20MM PROMUS PREMIER DRUG-ELUTING STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM; HOWEVER, THE SHAFT BROKE APPROXIMATELY 100CM FROM THE HUB. THE DISTAL END OF THE DELIVERY SHAFT WAS STILL INSIDE THE GUIDE CATHETER AND THE REST OF THE DEVICE WAS OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE GUIDE CATHETER FROM THE PATIENT'S BODY AND RETRIEVED THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524703 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID #2134265-2018-06026. IT WAS REPORTED THAT PATIENT DISCOMFORT AND COMPLICATIONS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A PROMUS PREMIER¿ STENT WAS IMPLANTED THE OBTUSE MARGIN. AFTER THE PROCEDURE, UPON TRANSPORTATION BACK TO THE PATIENT'S ROOM, THE PATIENT BECAME DIAPHORETIC AND WAS BROUGHT BACK TO THE CATHETERIZATION LAB. THE PREVIOUSLY IMPLANTED STENT WAS WIDELY PATENT, HOWEVER, THERE WAS A FOCAL LESION IN THE RIGHT CORONARY ARTERY (RCA) THAT HAD BEEN UNDETECTED. A PROMUS PREMIER¿ STENT WAS THEN PLACED IN THE RCA. AFTER THE SECOND STENT WAS IMPLANTED, THE PATIENT'S ARM WAS "FROZEN" AND SEVERELY UNCOMFORTABLE. THE PATIENT'S CURRENT STATUS IS OKAY.

  Patient problems: Diaphoresis; Discomfort; Paralysis

  MAUDE report 7682085 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00X20MM PROMUS PREMIER¿ STENT WAS ADVANCED FOR TREATMENT AND WAS SUCCESSFULLY DEPLOYED. HOWEVER, WHEN THE STENT DELIVERY SYSTEM WAS REMOVED POST-STENT DEPLOYMENT, IT WAS NOTED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7574828 ↗
• MalfunctionMay 3, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED; HOWEVER, IT WAS NOTED THAT A STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540052 ↗