Promus PREMIER™ H7493952820300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729844792), received between Dec 1, 2016 and Jun 6, 2019 — classified as 1 injury, 7 malfunctions.

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

• InjuryJun 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT INSIDE PATIENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LEFT LEG. A 3.00X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF OF THE DELIVERY SYSTEM BEFORE IT WAS DEPLOYED. THE STENT HAD TO BE CRUSHED AGAINST THE WALL IN THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AND ENDO-TRASHED IN THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677151 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-APR-2018. A 3.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, UPON REVIEW OF THIS DEVICE, STENT DETACHMENT/SEPARATION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540344 ↗
• MalfunctionMay 8, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X20MM PROMUS PREMIER STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS ABOUT TO BE ADVANCED OVER THE WIRE, IT WAS NOTICED THAT THE TIP OF THE STENT WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 7496310 ↗
• MalfunctionOct 31, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT HALFWAY BETWEEN HUB AND DISTAL TIP WAS BROKEN. THE DEVICE WAS NEVER USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6990987 ↗
• MalfunctionApr 27, 2017Contamination; Contamination

  IT WAS REPORTED THAT PRODUCT STERILITY WAS COMPROMISED. A 3.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, THE STENT WAS OPENED AND CONTAMINATED IN THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6526804 ↗
• MalfunctionFeb 8, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE LESION WAS PREDILATED WITH AN EMERGE BALLOON CATHETER. A 3.00X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS KINKED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6310456 ↗
• MalfunctionFeb 2, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING THE UNPACKING OF A 3.00X20MM PROMUS PREMIER DRUG-ELUTING STENT, THE STENT SHAFT BROKE WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING HOOP. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A 3.0X12MM PROMUS DRUG-ELUTING STENT, DEPLOYED AT 16 ATMOSPHERES FOR 8 SECONDS, FOLLOWED BY POST-DILATATION WITH A 3.5X8MM NC QUANTUM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6296544 ↗
• MalfunctionDec 1, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00 X 20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. AS THE DEVICE WAS ADVANCED ONTO THE GUIDE WIRE, IT WAS NOTED THAT THE SHAFT BROKE WHILE INSERTING THROUGH THE TOUHY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6139065 ↗