BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 5098733 · Received September 23, 2015

    Report

    Report Number
    1416980-2015-36985
    Event Type
    Injury
    Date Received
    September 23, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DKZ
    PMA / PMN Number
    K983602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER FACILITY NAME: (B)(6). LITERATURE ARTICLE: MOON, R.C., TEIXEIRA, A.F., JAWAD, M.A. TREATMENT OF WEIGHT REGAIN FOLLOWING ROUX-EN-Y GASTRIC BYPASS: REVISION OF POUCH, CREATION OF NEW GASTROJEJUNOSTOMY AND PLACEMENT OF PROXIMAL PERICARDIAL PATCH RING. OBESITY SURGERY 24 (6) (PP 829-834), JAN. 2014 SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED SOMETIME BETWEEN DECEMBER 2009 AND APRIL 2013. 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 NAUSEA, VOMITING, AND DYSPHAGIA COINCIDENT WITH A ROUX-EN-Y GASTRIC BYPASS SURGERY IN WHICH VASCU-GUARD WAS USED. THE PATIENT EXPERIENCED THE NAUSEA AND VOMITING 40 DAYS POST-SURGERY AND WAS READMITTED TO THE HOSPITAL. 9 MONTHS POST-SURGERY, THE PATIENT EXPERIENCED DYSPHAGIA AND WAS AGAIN READMITTED TO THE HOSPITAL AND HAD AN OPERATION FOR THE REMOVAL OF THE VASCU-GUARD PATCH AND REVISION OF GASTROJEJUNOSTOMY ANASTOMOSIS. PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629509 VASCU-GUARD PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DKZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R