BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK MS-M

    MDR report key: 5253205 · Received November 28, 2015

    Report

    Report Number
    2183870-2015-00499
    Event Type
    Injury
    Date Received
    November 28, 2015
    Date of Event
    September 12, 2012
    Report Date
    October 4, 2013
    Manufacturer
    PLYMOUTH
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT BALLOON ANGIOPLASTY AND ATHERECTOMY OF LEFT ARTERIA FEMORALIS COMMUNIS DURING INDEX PROCEDURE. APPROXIMATELY 9 MONTHS POST PROCEDURE THE PATIENT PRESENTED WITH RESTENOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. IT IS REPORTED THAT THE EVENT WAS RELATED TO THE TARGET LESION. THE EVENT WAS REPORTED TO BE NOT RELATED TO THE STUDY PROCEDURE OR PLAQUE EXCISION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783625 SILVERHAWK MS-M CATHETER, PERIPHERAL, ATHERECTOMY MCW PLYMOUTH P4056 9513596

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention