Promus PREMIER™ H7493952838350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729845034), received between Dec 1, 2016 and Nov 20, 2018 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, BEFORE THE DEVICE WAS INSERTED, IT WAS NOTED THAT THE STENT HAD A FRAYED EDGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50X38MM PROMUS PREMIER DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MANUFACTURER: A PROMUS PREMIER, US, MR 3.50 X 38 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT WAS DAMAGED ON THE 7TH AND 9TH PROXIMAL STENT STRUT ROW WITH STENT STRUTS LIFTED. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. STENT DAMAGE MOST LIKELY OCCURRED DURING PREPARATION WHEN THE STENT PROTECTOR WAS REMOVED. 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 MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG SEVERAL LOCATIONS OF THE HYPOTUBE SHAFT DURING ANALYSIS. THIS TYPE OF

  Patient problems: No Patient Involvement

  MAUDE report 8088748 ↗
• MalfunctionMay 15, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE DISTAL LEFT MAIN (LM) ARTERY TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PRE-DILATATION WITH A 3.0X8 NC QUANTUM BALLOON CATHETER, A 3.50X38MM PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WOULD NOT GO DOWN INTO THE LAD AND WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A 3.0X38MM PROMUS PREMIER STENT WITHOUT ANY ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515341 ↗
• MalfunctionOct 26, 2017Fracture; Fracture

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X38MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT STRUTS WERE FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980736 ↗
• MalfunctionOct 3, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE BUT WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR ADVERSE CONDITIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6912268 ↗
• InjuryDec 15, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH (B)(4) THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. WHILE ATTEMPTING TO DEPLOY A 3.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT, THE STENT CAME OFF THE BALLOON AND LODGED IN THE BODY. THE PHYSICIAN WAS ABLE TO MOVE THE STENT TO THE FEMORAL ARTERY AND WAS REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177024 ↗
• MalfunctionDec 1, 2016Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 6F MACH1 GUIDE CATHETER CROSSED THE LESION, A 3.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN ADVANCED THROUGH THE MACH1 GUIDE CATHETER TO TREAT THE LESION. HOWEVER, A KINK WAS NOTICED ON THE GUIDE CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE PROMUS PREMIER¿ STENT THRU THE GUIDE CATHETER, IT LOOKED LIKE THE EDGE OF THE STENT WAS LIFTED. BOTH DEVICES WERE THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE CATHETER AND A 3X38MM PROMUS STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6139354 ↗