Promus PREMIER™ H7493952816250Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729844716), received between Nov 17, 2016 and Dec 19, 2018 — classified as 5 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE DEVICE WAS REMOVED AND 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 8182364 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X16MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) WAS FRACTURED WHILE TRYING TO CROSS THE LESION. THE FRACTURE OCCURRED OUTSIDE OF THE PATIENT, SO THE ENTIRE SDS WAS REMOVED. A NEW PROMUS PREMIER DES WAS IMPLANTED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED FROM THE LABORATORY IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112648 ↗
• MalfunctionJul 31, 2018Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT CATHETER WITHDRAWAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTANT RIGHT CORONARY ARTERY. A 2.50X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT WAS UNABLE TO DELIVER TO THE TARGET LESION. SUBSEQUENTLY, THE DEVICE WAS ATTEMPTED TO BE PULLED BACK INTO THE GUIDE CATHETER BUT DIFFICULTY WAS ENCOUNTERED. THE ENTIRE SYSTEM WAS PULLED OUT AND THE STENT WAS FOUND MINGLED UP INTO THE GUIDE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737266 ↗
• MalfunctionJul 13, 2018Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS BENT. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7687230 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID # 2134265-2018-06025. IT WAS REPORTED THAT PATIENT DISCOMFORT AND COMPLICATIONS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A PROMUS PREMIER¿ STENT WAS IMPLANTED THE OBTUSE MARGIN. AFTER THE PROCEDURE, UPON TRANSPORTATION BACK TO THE PATIENT'S ROOM, THE PATIENT BECAME DIAPHORETIC AND WAS BROUGHT BACK TO THE CATHETERIZATION LAB. THE PREVIOUSLY IMPLANTED STENT WAS WIDELY PATENT, HOWEVER, THERE WAS A FOCAL LESION IN THE RIGHT CORONARY ARTERY (RCA) THAT HAD BEEN UNDETECTED. A PROMUS PREMIER¿ STENT WAS THEN PLACED IN THE RCA. AFTER THE SECOND STENT WAS IMPLANTED, THE PATIENT'S ARM WAS "FROZEN" AND SEVERELY UNCOMFORTABLE. THE PATIENT'S CURRENT STATUS IS OKAY.

  Patient problems: Diaphoresis; Discomfort; Paralysis

  MAUDE report 7682078 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID 2134265-2018-03604 AND 2134265-2018-03607. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY TORTUOUS AND HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X38 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED, THEN A 2.50X20 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED, BUT ALSO FAILED TO CROSS THE LESION AND WAS DAMAGED. A 2.50X16 MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN IMPLANTED IN LAD, THEN A 2.50 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED DISTAL TO THE LESION. BUT WHEN THE STENT WAS DEPLOYED, THE BALLOON RUPTURED AND BECAME STUCK ON EITHER THE CALCIUM OR THE STENT STRUTS AND THE BALLOON CATHETER WAS DIFFICULT TO REMOVE. EVENTUALLY, THE BALLOON CATHETER WAS REMOVED AND THE STENT WAS IMPLANTED. HOWEVER, WHEN THE PATIENT WAS SOMEWHAT STABILIZED, IT WAS NOTED THAT THE LAD HAD ACTUALLY DISSECTED DISTAL TO THE STENT. IT WAS THEN DECIDED TO SEND THE PATIENT FOR SURGERY DUE TO THE DISTAL DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S POST-SURGICAL CONDITION WAS STABLE.

  Patient problems: Intimal Dissection

  MAUDE report 7469122 ↗
• InjuryJan 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL VESSEL. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO DILATE THE LESION. HOWEVER, THE STENT WAS LOST IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND SNARING WAS ATTEMPTED AT THE RIGHT PROFUNDA. SUBSEQUENTLY, THE PATIENT WAS SENT FOR A COMPUTED TOMOGRAPHY SCAN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165212 ↗
• InjuryOct 24, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS GIVEN ANTI-PLATELET MEDICATION BEFORE AND DURING THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED WHICH LED TO THE DISCOVERY OF THROMBOSIS. A NON-BSC STENT WAS ALSO DEPLOYED IN ADDITION TO THE 3.0MM X 12MM PROMUS STENT THAT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS ALSO GIVEN ANTI-PLATELET MEDICATION AT THE TIME OF DISCHARGE AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 6970888 ↗
• InjuryJan 19, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2016. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT AND HYPOTUBE BREAK. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE STENT DISLODGED IN THE RIGHT CORONARY ARTERY AND WAS SUBSEQUENTLY SNARED OUT OF THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6265021 ↗
• MalfunctionJan 17, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, WHEN THE DEVICE WAS LOADED ONTO THE WIRE, THE DEVICE BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6255899 ↗
• MalfunctionNov 17, 2016Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X16MM PROMUS PREMIER" DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6109860 ↗