BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCU-GUARD

    MDR report key: 337411 · Received June 11, 2001

    Report

    Report Number
    2183620-2001-00012
    Event Type
    Other
    Date Received
    June 11, 2001
    Date of Event
    May 18, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT A LEFT CAROTID ENDARTERECTOMY. A COMPLETION DOPPLER WAS PERFORMED AND SURGEON STATED IT WAS "PRETTY GOOD" AND THE ANASTOMOSIS AND VASCU-GUARD PATCH LOOKED GOOD. THE WOUND WAS CLOSED AND THE PT WAS TAKEN TO RECOVERY. DUE TO SOME SLIGHT WOUND OOZING, THE INFUSION OF "LMD" WAS DISCONTINUED. AFTER SPEAKING TO THE FAMILY, THE SURGEON CHECKED THE PT AND FOUND PATIENT TO BE AWAKING NORMALLY WITH NO APPARENT NEUROLOGIC ABNORMALITIES. ABOUT 20 MINUTES LATER NEURO-DIFFICULTIES AROSE WITH BILATERAL WEAKNESS. ULTRASOUND EXAM REVEALED THE ARTERY TO BE PATENT, BUT WITH INCREASED VELOCITIES AT BOTH THE PROXIMAL AND DISTAL ANASTOMOTIC SITES. BY THIS TIME IT WAS CLINICALLY APPARENT THAT THE PT WAS HAVING AN ACUTE STROKE AND PT WAS RETURNED TO THE OPERATING ROOM FOR RE-EXPLORATION. THE ANASTOMOTIC SITE WAS INTACT WITH NO LEAKAGE. THE ARTERY APPEARED PATENT. WHEN OPENED AT THE SUTURE LINE, THERE APPEARED TO BE "PLATELET PLUGS" AT THE ENDARTERECTOMY END POINTS OF BOTH THE "CCA" AND "ICA". THE VASCU-GUARD PATCH WAS REMOVED, THE ARTERIOTOMY ENLARGED, AND PATCHED WITH AN IMPREGNATED DACRON PATCH. THE PT WAS DISCHARGED WITHIN THE FOLLOWING WEEK WITH SLIGHT NEURO-DEFICITS.

    Description of Event or Problem · 1

    THIS SURGEON'S STANDARD POST-OP CARE INCLUDES LMD INFUSION, WHICH WAS DISCONTINUED EARLIER THAN USUAL IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26770 VASCU-GUARD PERIPHERAL VASCULAR PATCH DSY BIO-VASCULAR VG-0108S 533866

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention