BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4393917 · Received January 7, 2015

    Report

    Report Number
    2134265-2014-08275
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    July 4, 2014
    Report Date
    December 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT CORONARY ARTERY DISSECTION OCCURRED. IN (B)(6) 2014, THE PATIENT PRESENTED DUE TO ASYMPTOMATIC ISCHEMIA AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THE 15 X 2.3 MM, NEW, CONCENTRIC, TYPE B1 AND 90% STENOSED TARGET LESION CONTAINED IN A <= 45 DEGREE ANGULATION AND WITH TMI FLOW 3 WAS LOCATED IN THE MID-DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS TREATED WITH PLACEMENT OF A 2.25 MM PROMUS PREMIER OUE MR DRUG ELUTING STENT. FOLLOWING POST DILATATION, CORONARY ARTERY DISSECTION WAS NOTED IN THE DISTAL LAD AND A 16 X 2.25 PROMUS PREMIER OUS MR WAS DEPLOYED AT 8 ATMOSPHERES TO TREAT THE DISSECTION. POST PROCEDURE, TMI FLOW 3 WAS RESTORED WITH 0% VISUAL RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED. THE PHYSICIAN THOUGHT THAT THE 1ST STENT (2.25 PROMUS PREMIER STENT) WAS THE CAUSE OF THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12189 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention