BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963628 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00136
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    March 5, 2009
    Report Date
    March 5, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS OBSERVED THAT THE DASHED REFERENCE LINES ARE MISSING TOWARDS THE TIP OF THE GRAFT, IT IS LIKELY THAT THE EPTFE RADIAL REINFORCEMENT WRAP WAS REMOVED IN THIS AREA. BASED ON THE OBSERVATIONS, MECHANICAL TESTING AND FURTHER DISCUSSION WITH THE SALES REPRESENTATIVE, IT APPEARS THAT THE EPTFE RADIAL REINFORCEMENT LAYER MAY HAVE BEEN DAMAGED OR PEELED OFF WHEN THE HELIX WAS REMOVED TO PREPARE THE GRAFT FOR THE ANASTOMOSIS IN THE LOCATION IN QUESTION. IF THIS OCCURRED, THE SUTURE RETENTION STRENGTH COULD HAVE BEEN LOWERED IN THIS SMALL LOCALIZED AREA. THE RECORDS FOR THIS LOT OF GRAFT MATERIAL WERE REVIEWED AND NO ABNORMALITIES WERE SEEN. ALL RECORDS, DATA AND OBSERVATIONS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. WITH THE GIVEN INFORMATION WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE SUTURE PULLING OUT OF THE GRAFT, ALTHOUGH IT IS LIKELY THAT THE RADIAL REINFORCEMENT WRAP WAS INADVERTENTLY REMOVED WHEN THE HELIX WAS PEELED AWAY FROM SUTURING.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A RIGHT FEM/POP SURGERY. THE SUTURES (6-0 PROLENE C1 SUTURES) PULLED THROUGH AND THE GRAFT SHREDDED. ACCORDING TO THE SALES REPRESENTATIVE'S NOTES, THE SURGEON WAS PERFORMING A RIGHT LEG FEMOROPOPLITEAL BYPASS WITH THE VXT GRAFT, AND WAS USING 6-0 PROLENE C1 SUTURES FOR THE ANASTOMOSES (NON-CUTTING NEEDLES). THE (B)(6) MALE PATIENT ALREADY HAD A TEXTILE GRAFT IN THE RIGHT AXILLARY BIFEMORAL POSITION, SO THE DISTAL ANASTOMOSIS WAS MADE TO THE TEXTILE GRAFT. THE VXT GRAFT WAS TUNNELED DISTAL TO PROXIMAL USING GDS, AND THE DISTAL ANASTOMOSIS, THE SUTURES PULLED THROUGH AND THE GRAFT SHREDDED. THE PHYSICIAN THEN USED A PIECE OF THE EXCESS VXT TO MAKE A NEW PROXIMAL ANASTOMOSIS AND SUTURED THE END OF THAT GRAFT SEGMENT TO THE END OF THE DISTAL VXT SEGMENT TO COMPLETE THE BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963 ADVANTA VXT DSY ATRIUM MEDICAL CORP. 22225 AH14202

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 6-0 PROLENE C1 SUTURES