BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3940872 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04186
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 15, 2013
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 95% STENOSED, ECCENTRIC SHAPED, 20MM IN LENGTH, IN-STENT RESTENOSIS TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS, 2.5MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED. THIS 2.50X24MM PROMUS ELEMENT ¿ WAS DEPLOYED HOWEVER, ECHOCARDIOGRAM REVEALED IN-STENT RESTENOSIS. IT WAS NOTED THAT ANOTHER PTCA IS PENDING FOR TREATMENT OF THE RESTENOSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PRE-DILATION WAS COMPLETED WITH A 2.5X15MM BALLOON CATHETER AND THIS 2.5X24MM PROMUS ELEMENT STENT WAS INFLATED TO 16 ATM. THE PROXIMAL SEGMENT OF THE STENT WAS POST DILATED WITH A 2.7X12MM BALLOON CATHETER AT 15 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418382 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 15307940

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention