BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3163368 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03864
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT. FOLLOWING DEPLOYMENT OF THE 2.75X20MM PROMUS PREMIER STENT THE PHYSICIAN NOTED THAT THE STENT APPEARED KINKED. THE STENT WAS POST-DILATED HOWEVER IT DID NOT CHANGE THE APPEARANCE OF THE STENT. PHYSICIAN NOTED THAT THE STENT WAS WELL APPOSED AND NO FURTHER INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT. FOLLOWING DEPLOYMENT OF THE 2.75X20MM PROMUS PREMIER STENT THE PHYSICIAN NOTED THAT THE STENT APPEARED KINKED. THE STENT WAS POST-DILATED HOWEVER IT DID NOT CHANGE THE APPEARANCE OF THE STENT. PHYSICIAN NOTED THAT THE STENT WAS WELL APPOSED AND NO FURTHER INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264125 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120270 16006329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention