Promus PREMIER™ H7493952838250Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729845003), received between Nov 22, 2016 and Apr 19, 2018 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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.

• MalfunctionApr 19, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS DEFORMED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7444236 ↗
• MalfunctionMar 13, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, UPON REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE GUIDE CATHETER, THE BALLOON DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336121 ↗
• DeathOct 30, 2017Entrapment of Device; Device Dislodged or Dislocated; Torn Material; Entrapment of Device; Device Dislodged or Dislocated; Torn Material

  IT WAS REPORTED A BALLOON TEAR, STENT ENTRAPMENT, AND STENT DISLODGEMENT OCCURRED. THE PATIENT EXPERIENCED IN-STENT RESTENOSIS OF AN UNKNOWN STENT, PREVIOUSLY PLACED IN THE CIRCUMFLEX. DURING A PROCEDURE TO ADDRESS THE RESTENOSIS, INFORMATION SUGGESTED A BALLOON WAS INFLATED IN THE PREVIOUSLY PLACED STENT PRIOR TO ADVANCING THE 2.5 X 38 MM PROMUS PREMIER¿ DRUG-ELUTING STENT. HOWEVER, THE STENT DELIVERY SYSTEM WAS ONLY ABLE TO ADVANCE HALFWAY THROUGH THE PREVIOUSLY PLACED STENT, AND THE PROMUS PREMIER¿ WAS THEN STUCK IN THE PREVIOUSLY PLACED STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM, BUT IT WAS NOT ABLE TO BE REMOVED. A SNARE WAS USED IN AN ATTEMPT TO REMOVE THE STENT AND DELIVERY SYSTEM; HOWEVER, DURING REMOVAL, A DISTAL PORTION OF THE BALLOON TORE OFF AND THE STENT DISLODGED AND FELL INTO THE AORTA. THE PATIENT UNDERWENT SURGERY, DURING WHICH THE STENT WAS RETRIEVED FROM THE AORTA AND THE ORIGINAL PROCEDURE WAS COMPLETED. THE BALLOON FRAGMENT REMAINED STUCK IN THE CIRCUMFLEX; THAT AREA OF THE CIRCUMFLEX WAS BYPASSED DURING SURGERY. THE PATIENT SURVIVED SURGERY, BUT DIED A NUMBER OF HOURS FOLLOWING THE PROCEDURE. THE CAUSE OF DEATH WAS NOT KNOWN.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 6987232 ↗
• MalfunctionOct 3, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X38MM 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 6912292 ↗
• MalfunctionSep 6, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846224 ↗
• InjuryApr 19, 2017Bent; Bent

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPNEA, AND STENT DAMAGE AND OCCLUSION OCCURRED. IN (B)(6) 2016, A 2.50X38MM PROMUS PREMIER¿ DRUG-ELUTING WAS IMPLANTED FOR TREATMENT. HOWEVER, IN 2017, THE PATIENT STARTED TO HAVE DIFFICULTIES IN BREATHING. THE PATIENT CONTACTED THE HOSPITAL WHERE THE PROCEDURE WAS PERFORMED BUT DID NOT RECEIVE ANY CALL BACK. THREE OR FOUR WEEKS LATER, THE HOSPITAL CALLED THE PATIENT BACK AND SCHEDULED THE PATIENT FOR A STRESS TEST. IN THE MEANTIME, THE PATIENT SOUGHT SECOND OPINION FROM A PHYSICIAN FROM ANOTHER HOSPITAL. OVER THE FOLLOWING WEEK, THE PATIENT'S CONDITION WORSENED TO THE POINT OF HAVING DIFFICULTIES GETTING OUT OF BED IN THE MORNING, HAVING NO ENERGY, AND DIFFICULTIES IN BREATHING PERSISTED. THE PATIENT FELT ILL, WAS SCARED, AND WAS THROWING UP. IN (B)(6) 2017, THE PATIENT UNDERWENT A NUCLEAR STRESS TEST AND IT WAS NOTED THAT THE PREVIOUSLY IMPLANTED STENT WAS COMPLETELY SMASHED AND THERE WAS ALL KINDS OF BLOCKAGE. THE PATIENT WAS ADMITTED TO THE SECOND HOSPITAL AND UNDERWENT A HEART CATHETERIZATION. THE PHYSICIAN USED A BALLOON CATHETER TO OPEN UP THE PREVIOUSLY IMPLANTED STENT AND THE PATIENT STARTED TO BREATH PRETTY WELL. THE PROCEDUR

  Patient problems: Dyspnea; Occlusion; Vomiting

  MAUDE report 6503081 ↗
• InjuryMar 7, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DAMAGE AND INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE 2ND DIAGONAL BRANCH. INFLATION OF THE 2.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ATTEMPTED AT 10ATM BUT WAS ONLY ABLE TO INFLATE TO 8ATM. WHEN THE STENT DELIVERY SYSTEM WAS PULLED OUT, THE STENT ELONGATED ALL THE WAY OUT INTO THE AORTA. SUBSEQUENTLY, A 3X18MM NON-BSC STENT WAS DEPLOYED TO TAP THE STENT UP AGAINST THE VESSEL WALL. THE PROMUS PREMIER¿ STENT COULD STILL BE SEEN HANGING OUT INTO THE AORTA. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. THE PATIENT WAS PLANNED TO BE KEPT ON LIFELONG ANTIPLATELET MEDICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6384189 ↗
• MalfunctionNov 22, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE HYPOTUBE WAS BROKEN. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY BY SIMPLY PULLING OUT THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6121067 ↗