Promus PREMIER™ H7493952812220Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729844648), received between Mar 7, 2017 and Dec 24, 2018 — classified as 3 injuries, 7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X12MM PROMUS PREMIER STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE PHYSICIAN BENT THE HYPOTUBE TO THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8193610 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25MM X 12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING THE DEVICE THROUGH A NON-BSC BLEEDBACK CONTROL VALVE, THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED BY PULLING THE STENT SYSTEM OUT FROM THE PATIENT'S BODY. 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 8182274 ↗
• InjuryDec 12, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT ARTERY DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS USED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE THE ARTERY A NON FLOW LIMITING DISSECTION OCCURRED. THE PHYSICIAN USED A DIFFERENT DEVICE TO OVERLAP THE DISSECTED ARTERY. NO SERIOUS INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 8157611 ↗
• MalfunctionJan 15, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ADVANCING, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM (SDS) BROKE HALFWAY. THE DEVICE WAS PULLED OUT AND THE BROKEN SDS CAME WITH IT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191181 ↗
• MalfunctionNov 27, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT A STENT STRUT WAS LIFTED UP. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059457 ↗
• MalfunctionAug 31, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  SAME CASE AS MDR ID# 2134265-2017-08691. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X24MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DISTAL TIP OF THE BALLOON RUPTURED AND THE STENT WAS NOT IMPLANTED. SUBSEQUENTLY, A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT A DIFFERENT VESSEL. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT APPEARED TO BE DAMAGED AND WAS NOT CRIMPED WELL ON THE BALLOON. THE DEVICE NEVER ENTERED THE PATIENT'S BODY 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 Patient Involvement

  MAUDE report 6833936 ↗
• MalfunctionAug 2, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED WITH A 2.0X12MM APEX BALLOON CATHETER, A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 2.25X12MM PROMUS STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760501 ↗
• MalfunctionJun 29, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT BUCKLED IN THE TOUHY AND FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6677527 ↗
• InjuryMay 31, 2017Break; Difficult to Remove; Activation, Positioning or Separation Problem; Break; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT INADEQUATE APPOSITION, SHAFT BREAK, BALLOON REMOVAL DIFFICULTY AND VESSEL OCCLUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.25X12MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED THROUGH THE NON-BSC GUIDE EXTENSION CATHETER AND STENT WAS THEN DEPLOYED AT 16 ATMOSPHERES. THE BALLOON DEFLATED BUT THERE WAS A WAIST IN THE MIDDLE OF THE STENT AFTER THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DELIVERY CATHETER. THE DELIVERY CATHETER SEPARATED AND THE BALLOON WAS TRAPPED INSIDE THE STENT. THE BALLOON OCCLUDED THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO SNARE THE BALLOON OUT BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PATIENT UNDERWENT FOR AN EMERGENT OPEN HEART SURGERY. THE PORTION OF THE CATHETER THAT REMAINED INSIDE THE PATIENT WAS SURGICALLY RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6601023 ↗
• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR CASE # 2134265-2017-01459 AND 2134265-2017-01571. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND CHEST PAIN OCCURRED. IN (B)(6) 2017, 2 TARGET LESIONS WERE IDENTIFIED. THE TARGET LESION#1 WAS LOCATED IN THE SECOND OBTUSE MARGINAL. TARGET LESION#2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). 2000 UNITS OF HEPARIN WAS GIVEN. TARGET LESION#1 WAS THEN TREATED WITH 2.50 X 12 SYNERGY II DRUG-ELUTING STENT (DES) AND 2.25X12MM PROMUS PREMIER¿ DES. TARGET LESION#2 WAS TREATED WITH A 2.75X32MM PROMUS PREMIER¿ DES AND THE PROCEDURE WAS COMPLETED. THE FOLLOWING DAY, THE PATIENT PRESENTED DUE TO CHEST PAIN AND ELECTROCARDIOGRAM WAS PERFORMED. IT WAS THEN NOTED THAT THE PORTION OF THE SMALL CIRCUMFLEX ARTERY WAS OCCLUDED. 4000 UNITS OF HEPARIN WAS GIVEN AND A 2.25X15MM EMERGE BALLOON CATHETER WAS THEN ADVANCED AND DILATED THE OCCLUDED AREA FOR 6 INFLATIONS. THE PATIENT'S STATUS WAS STABLE AND THE PATIENT WAS THEN DISCHARGED.

  Patient problems: Chest Pain; Occlusion

  MAUDE report 6385573 ↗