Promus PREMIER™ H7493952832250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844952), received between Nov 21, 2016 and Dec 16, 2019 — classified as 1 death, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathDec 16, 2019Defective Device; Defective Device

  SAME CASE AS MDR: (B)(4) AND (B)(4). IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED AND PATIENT EXPERIENCED ACUTE THROMBOSIS AND DIED. THE HIGHLY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER CROSSING THE LESION WITH AN UNSPECIFIED GUIDEWIRE, TWO UNSPECIFIED BALLOON CATHETERS WERE ADVANCED WITH DIFFICULTY DUE TO THE CALCIFICATION. A 2.5X38MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE MID LAD. FOLLOWING IMPLANT, A DISTAL DISSECTION WAS NOTED ALONG WITH 18MM OF DISEASE THAT ALSO NEEDED TO BE TREATED. A 3.5X32MM PROMUS PREMIER DES WAS PROXIMALLY OVERLAPPED THE INITIALLY PLACED STENT. ANOTHER 2.5X32MM PROMUS PREMIER WAS ADVANCED DISTALLY THROUGH BOTH STENTS BUT WOULD NOT DELIVER DESPITE PUSHING HARD. THE DEVICE WAS REMOVED AND THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON CATHETER. THE 2.5X32MM STENT WAS READVANCED BUT WAS STILL UNSUCCESSFUL. THE DEVICE WAS REMOVED HOWEVER, THE STENT STARTED STRIPPING OFF THE BALLOON AND ACCORDIONED INSIDE THE PREVIOUS DEPLOYED STENTS. THE PHYSICIAN ATTEMPTED TO REMOVED THE DISLODGED STENT THAT BECAME STUCK IN THE PROXIMAL LAD. THE ARTERY STARTED TO CLOT AFTER 30 MINUTES AND A VENTRI

  Patient problems: Death; Thrombosis

  MAUDE report 9474802 ↗
• MalfunctionNov 1, 2017Entrapment of Device; Fracture; Entrapment of Device; Fracture

  SAME CASE AS MDR ID: 2134265-2017-10552. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A CHRONIC TOTAL OCCLUSION, THE STENT DELIVERY SYSTEM STUCK TO THE GUIDE WIRE AND THE CATHETER SHAFT BROKE. THE CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN WAS ABLE TO CROSS THE LESION AND DILATE SEVERAL TIMES WITH A BALLOON. A 300CM STRAIGHT TIP SAMURAI GUIDE WIRE WAS PLACED IN THE DISTAL VESSEL. A 2.50 X 32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. UPON REMOVAL FROM THE BODY, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE PROXIMAL PORTION OF THE GUIDE WIRE. WHILE TRYING TO REMOVE THE STENT DELIVERY SYSTEM FROM THE WIRE, THE CATHETER SHAFT SEPARATED AT THE WIRE EXIT PORT. ALL COMPONENTS WERE OUTSIDE OF THE BODY; NO DEVICE FRAGMENTS SEPARATED WITHIN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE LESION WAS SUCCESSFULLY STENTED WITH A NEW 2.5 X 32MM STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6993212 ↗
• MalfunctionApr 18, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY GRAFT TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 190 CM FILTERWIRE EZ¿ WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE FILTERWIRE FAILED TO CROSS THE LESION. THE DEVICE WAS THEN REMOVED AND IT WAS NOTED THAT THE TIP WAS DAMAGED. SUBSEQUENTLY, ANOTHER FILTERWIRE WAS ADVANCED AND WAS ABLE TO TREAT THE LESION. A 2.50X32MM PROMUS PREMIER¿ STENT WAS ALSO ADVANCED TO TREAT THE LAD PORTION. MOREOVER, THE SHAFT BROKE IN HALF. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6500930 ↗
• MalfunctionNov 21, 2016Bent; Entrapment of Device; Bent; Entrapment of Device

  IT WAS REPORTED THAT STENT DAMAGE AND CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE VESSEL. A 2.50X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, AS THE STENT WAS LOADED ONTO THE WIRE, OUTSIDE OF THE BODY, IT WOULD NO LONGER ADVANCE ON THE WIRE. THE PROXIMAL END OF THE STENT CRUMPLED ON THE BALLOON. THE PHYSICIAN ATTEMPTED TO REMOVE THE ENTIRE DELIVERY SYSTEM FROM THE WIRE AS IT HAD NOT ENTERED THE PATIENT¿S BODY BUT WAS UNABLE TO. THE ENTIRE STENT DELIVERY SYSTEM WAS REMOVED FROM THE WIRE AFTER A BLADE WAS USED TO STRIP THE STENT OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6118460 ↗