Promus PREMIER™ H7493952838300Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729845027), received between Feb 15, 2017 and May 7, 2020 — classified as 2 injuries, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE LOADING THE DELIVERY SYSTEM ONTO A NON-BSC GUIDEWIRE, THE STENT CAME OFF THE BALLOON. THE STENT DELIVERY SYSTEM WAS PULLED OUT OFF THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A 3.00X32MM SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036566 ↗
• InjuryJun 28, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID # 2134265-2018-06112. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2012 A 3.5X32MM PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED IN THE SAPHENOUS VEIN GRAFT(SVG) AND IN (B)(6) 2016 A 3.00X38MM PROMUS PREMIER¿ STENT WAS IMPLANTED PARTIALLY OVERLAPPING THE PROMUS ELEMENT. IN (B)(6) 2018 THE STENTS WERE NOTED TO HAVE RESTENOSED. A 10MMX3.00MM WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL® WAS ADVANCED IN AN ATTEMPT TO DILATE AND FAILED TO CROSS THE ISR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7645708 ↗
• MalfunctionMar 13, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00X38MM PROMUS PREMIER¿ STENT WAS SELECTED FOR USE. THE DEVICE WAS LOADED ONTO THE WIRE AND WHILE INSERTING IT INTO THE SHEATH, IT WAS NOTED THAT THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7334144 ↗
• MalfunctionFeb 8, 2018Component Incompatible; Component Incompatible

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-JAN-2018. IT WAS REPORTED THAT CONNECTION INCOMPATIBILITY OCCURRED. A 3.00 X 38 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE STENT DELIVERY SYSTEM (SDS) WAS CONNECTED TO A BSC INFLATION DEVICE, THE SDS WOULD NOT CONNECT SECURELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 38 MM PROMUS DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED/SEPARATED STENT.

  Patient problems: No Patient Involvement

  MAUDE report 7251278 ↗
• MalfunctionOct 12, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A GUIDE WAS PLACED IN THE LESION, A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ATTEMPTED TO BE ADVANCED BUT THE SHAFT OF THE STENT BROKE AT ABOUT MIDWAY UP. THE BREAK OCCURRED OUTSIDE THE PATIENT'S BODY SO THE DEVICE WAS ABLE TO BE REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6944241 ↗
• MalfunctionJun 20, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT, IT WAS NOTED THAT THE HYPOTUBE WAS FRACTURED AND BROKEN. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 3.0X38MM PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6654179 ↗
• MalfunctionApr 18, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2017-03358. IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING PREPARATION, THE STENT CAME OUT OF ITS HOOP WITH THE EDGE OF THE STENT STRUTS DEFORMED. THE DEVICE WAS NOT USED INSIDE THE PATIENT. A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE THE DEVICE BECAME STUCK WITH THE NON-BSC GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499611 ↗
• MalfunctionApr 11, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT, WHEN THE DEVICE WAS REMOVED FROM THE HOOP AND PROTECTOR, IT WAS NOTED THAT ONE OF THE STENT STRUT WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6481978 ↗
• MalfunctionApr 5, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS FRAYED AND THE DEVICE FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6459856 ↗
• InjuryApr 3, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT STENT RESTENOSIS OCCURRED AND THE PATIENT EXPERIENCED UNSTABLE ANGINA AND ELEVATED TROPONINS. IN (B)(6) 2014 3.00 X 38 MM PROMUS PREMIER¿ STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2017, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND SLIGHTLY ELEVATED TROPONIN LEVELS; 90% FOCAL IN-STENT RESTENOSIS (ISR) WAS NOTED. THE FOLLOWING DAY, SURGERY WAS PERFORMED AND PREDILATION WAS COMPLETED WITH A 3.00 X 15 MM BALLOON FOLLOWED BY THE IMPLANT OF A 3.50 X 20 MM SYNERGY STENT, RESULTING IN 0% STENOSIS AND RESTORED TIMI 3 FLOW. THE PATIENT WENT HOME LATER THAT DAY AN THE PHYSICIAN FELT THAT THE RESULTS WERE "EXCELLENT."

  Patient problems: Angina; Cardiac Enzyme Elevation

  MAUDE report 6453673 ↗
• MalfunctionMar 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS FOUND. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. AFTER SEVERAL ATTEMPTS, IT WAS NOTED THAT THERE WAS A CHUCK OF PLASTIC OBSTRUCTING THE HUB. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6377190 ↗
• MalfunctionFeb 22, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. AFTER A GUIDEWIRE CROSSED THE LESION, A 3.00X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT THE DEVICE BECAME STUCK ON THE WIRE. BOTH OF THE DEVICES WERE REMOVED TOGETHER. USING THE SAME WIRE, A NEW PROMUS STENT WAS THEN AND ADVANCED AND DEPLOYED WHICH COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6350206 ↗
• MalfunctionFeb 15, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND WAS THEN RE-ADVANCED; HOWEVER, IT WAS NOTICED THAT ONE OF THE STENT STRUTS HAD BEEN DAMAGED AND PEELED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6332104 ↗