BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    MDR report key: 5075466 · Received September 14, 2015

    Report

    Report Number
    1416980-2015-35896
    Event Type
    Injury
    Date Received
    September 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PROSPECTIVE RANDOMIZED STUDY WAS DONE BETWEEN(B)(6) 2009 AND (B)(6) 2012. FROM LITERATURE: STONE, P.A., ABURAHMA, A., HASS, S., PHANG, D., MOUSA, A., MODAK, A., DEARING, D. PROSPECTIVE RANDOMIZED TRIAL ACUSEAL VS VASCU-GUARD PATCHING FOR CAROTID ENDARTERECTOMY J.VASC.SURG. 58(4): 1164-1165. 2013. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IPSILATERAL NEUROLOGIC EVENT (STROKE) AFTER UNDERGOING A SURGERY IN WHICH VASCU-GUARD WAS USED. ON AN UNREPORTED DATE, THE PATIENT UNDERWENT A CEA (CAROTID ENDARTERECTOMY) PROCEDURE. THE MORNING AFTER UNDERGOING THE CEA, THE PATIENT EXPERIENCED A STROKE. SPECIFIC TREATMENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS MANAGED CONSERVATIVELY WITH NO FURTHER NEUROLOGIC EVENT. NO OTHER NEUROLOGIC DEFICITS OCCURRED IN THE PERIOPERATIVE PERIOD. ON AN UNREPORTED DATE, THE PATIENT WAS FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606704 PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other