BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 8243409 · Received January 14, 2019

    Report

    Report Number
    2017233-2019-00015
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    May 25, 2018
    Report Date
    May 13, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ENTERED FOR THE FOLLOWING: RESULT CODE 213 WAS ADDED, REFER TO EXPLANT EVALUATION SUMMARY. UPDATED DEVICE CODE 2; RESULT CODE 2 AND CONCLUSION CODE 2. THE GORE® PROPATEN® VASCULAR GRAFT WAS RETURNED TO GEPROVAS, INDEPENDENT LABORATORY, FOR INVESTIGATION. THE SCOPE AND RESULTS OF THE INVESTIGATION WERE SUMMARIZED AND A REPORT WAS SUBMITTED TO W. L. GORE & ASSOCIATES. AN EXPLANT INVESTIGATOR (EI) AT W. L. GORE & ASSOCIATES REVIEWED THE REPORT. THE FOLLOWING IS A SUMMARY OF THE EI OBSERVATIONS: THE DEVICE FRAGMENT WAS GENERALLY DEVOID OF TISSUE ON THE ABLUMINAL SURFACES EXCEPT FOR A TAN/BROWN TISSUE ON THE ABLUMINAL SURFACE. NO CLEAR LUMINAL PHOTOGRAPHS OF H050060 WERE PROVIDED. LUMEN PATENCY FOR THE DEVICE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. ONE FRAGMENT CONTAINED TWO ATTACHED DEVICE FRAGMENTS: THE BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT (SB1601D) MAIN BODY AND BRANCH FRAGMENT: BELOW THE AREA OF BIFURCATION, ONE BRANCH HAD BEEN REMOVED AND ONE BRANCH WAS STILL ATTACHED. THE ATTACHED BRANCH WAS KINKED IN THE MIDDLE (LIKELY DUE TO TRANSPORT IN AN UNDERSIZED CONTAINER) AND HAD SERRATION MARKS NEAR THE DISTAL POLE. THE DISTAL POLE WAS TRANSECTED, BEVELED AND CONTAINED BLUE RUNNING SUTURE, INDICATING AN ANASTOMOTIC SITE. THE FRAGMENT LUMEN WAS OVULAR AND FLAT. THE PROPATEN® VASCULAR GRAFT FRAGMENT (H050060) WAS ATTACHED TO THE PROXIMAL PORTION OF SB1601D IN AN END TO SIDE CONFIGURATION, ABOVE THE AREA OF BIFURCATION, WITH WHITE RUNNING SUTURE. THE DISTAL POLE WAS TRANSECTED, FLATTENED AND OVULAR IN SHAPE. FROM GROSS IMAGES ALL MATERIAL DISRUPTIONS (I.E., MATERIAL TRANSECTIONS AND SERRATION MARKS), APPEAR TO BE CONSISTENT WITH CUTTING BY SHARP SURGICAL INSTRUMENTS (I.E., SCALPEL OR SCISSORS) AND CLAMPING BY A SURGICAL INSTRUMENT (I.E., FORCEPS OR SURGICAL CLAMP), LIKELY USED DURING A SURGICAL PROCEDURE. AS ADDITIONAL INFORMATION REVEALED THAT ALSO A BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT WAS INVOLVED IN THE MEDICAL DEVICE INCIDENT, THE SECOND GORE DEVICE WILL BE ALSO REPORTED TO THE FDA UNDER MFR REPORT #2017233-2019-00070.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ENTERED FOR THE FOLLOWING: 213: A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS CONFIRMED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS ADDITIONAL INFORMATION REVEALED THAT ALSO A BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT WAS INVOLVED IN THE MEDICAL DEVICE INCIDENT, THE SECOND GORE DEVICE WILL BE ALSO REPORTED TO THE FDA UNDER MFR REPORT #2017233-2019-00070.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE A BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED IN ORDER TO TREAT AN UNKNOWN DISEASE. ON (B)(6) 2016, A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED IN A 50-YEAR-OLD MALE PATIENT AS AN EXTENSION OF THE PREVIOUSLY IMPLANTED BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT IN ORDER TO TREAT A CRITICAL ISCHEMIA. ON (B)(6) 2018, AFTER ABOUT TWO YEARS, THE BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT AS WELL AS THE GORE® PROPATEN® VASCULAR GRAFT WAS EXPLANTED DUE TO A FALSE ANASTOMOTIC ANEURYSM AND AN INFECTION TO STAPHYLOCOCCUS AUREUS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2016, IN A (B)(6) MALE PATIENT AS AN EXTENSION OF AN AORTO-BIFURCATED-FEMORAL BYPASS IN ORDER TO TREAT A CRITICAL ISCHEMIA. ON (B)(6) 2018, AFTER ABOUT TWO YEARS, THE GORE® PROPATEN® VASCULAR GRAFT WAS EXPLANTED DUE TO A FALSE ANASTOMOTIC ANEURYSM AND AN INFECTION TO STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37649 GORE PROPATEN VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 4781553PP014

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention