BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX CARDIOVASCULAR PATCH

    MDR report key: 11689105 · Received April 19, 2021

    Report

    Report Number
    3007284313-2021-01396
    Event Type
    Death
    Date Received
    April 19, 2021
    Date of Event
    December 1, 2006
    Report Date
    April 19, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K811841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: VALVED PATCH FOR VENTRICULAR SEPTAL DEFECT WITH PULMONARY ARTERIAL HYPERTENSION. ABBAS AFRASIABI, MAHMOUD SAMADI, HOSSEIN MONTAZERGAEM, PUBLISHED IN ASIAN CARDIOVASCULAR AND THORACIC ANNALS, 2006 DEC; 14(6):501-4. AS THE DATE OF EVENT IS UNKNOWN, THE EVENT DATE USED WILL BE DECEMBER 1, 2006, AS THE ARTICLE WAS PUBLISHED DECEMBER 2006. THE GORE-TEX® CARDIOVASCULAR PATCH INSTRUCTIONS FOR USE STATES: USE OF THIS PRODUCT IN APPLICATIONS OTHER THAN THOSE INDICATED HAS THE POTENTIAL FOR SERIOUS COMPLICATIONS.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "VALVED PATCH FOR VENTRICULAR SEPTAL DEFECT WITH PULMONARY ARTERIAL HYPERTENSION" ABBAS AFRASIABI, MAHMOUD SAMADI, HOSSEIN MONTAZERGAEM, PUBLISHED IN ASIAN CARDIOVASCULAR AND THORACIC ANNALS, 2006 DEC; 14(6):501-4. THE ARTICLES OBJECTIVE/AIM IS TO REPORT OUR EXPERIENCE OF CLOSURE OF A LARGE VENTRICULAR SEPTAL DEFECT (VSD) IN PATIENTS WITH SEVERE PULMONARY HYPERTENSION, USING A VALVED PATCH. THE ARTICLE REPORTS FROM MARCH 1998 TO DECEMBER 2004, 16 ACYANOTIC PATIENTS AGED 2 TO 22 YEARS (MEAN, 7 ± 5.7 YEARS) WITH A LARGE VENTRICULAR SEPTAL DEFECT AND ELEVATED PULMONARY VASCULAR RESISTANCE (9.6 ± 3.8 WOOD UNITS) UNDERWENT SURGERY. A GORE-TEX PATCH WITH A 5¿8 MM LONGITUDINAL SLIT IN THE CENTER WAS USED. A PIECE OF PERICARDIUM WAS SEWN AROUND THE SLIT ON ONE SIDE OF THE PATCH, EXCEPT FOR THE UPPER QUARTER. IN ALL PATIENTS, THE DEFECT WAS CLOSED WITH A TRIMMED PATCH AND THE PERICARDIAL ASPECT WAS PLACED ON THE LEFT VENTRICULAR SIDE TO ALLOW RIGHT-TO-LEFT SHUNTING. ONE PATIENT DIED ON POSTOPERATIVE DAY 5 DUE TO PERSISTENT SEVERE PULMONARY ARTERIAL HYPERTENSION, A RIGHT-TO-LEFT SHUNT VIA THE VALVED PATCH, AND LOW SYSTEMIC OXYGEN SATURATION. THE ARTICLE INDICATES THIS IS AN OFF LABEL USE OF THE GORE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587416 GORE-TEX CARDIOVASCULAR PATCH PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death