BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 9901089 · Received March 30, 2020

    Report

    Report Number
    2017233-2020-00219
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    October 7, 2019
    Report Date
    July 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K904282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G5. COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES ADDITIONAL DEVICES REPORTED UNDER MFR REPORT NUMBERS: #2017233-2020-00220 AND #2017233-2020-00221.

    Additional Manufacturer Narrative · 1

    AS THE DEVICES WERE NOT RETURNED, NO EVALUATION OF THE DEVICES COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: FREQUENCY OF PERIGRAFT HYGROMA AFTER OPEN AORTIC RECONSTRUCTION. THE OBJECTIVE OF THE STUDY WAS TO ESTABLISH THE INCIDENCE OF AND DETERMINE THE RISK FACTORS ASSOCIATED WITH PERIGRAFT HYGROMA (PGH). PGH IS DEFINED AS A PERIGRAFT FLUID COLLECTION OF 30MM OR GREATER IN DIAMETER WITH A RADIODENSITY OF 30 OR FEWER HOUNSFIELD UNITS ON COMPUTED TOMOGRAPHY AT A MINIMUM OF 3 POSTOPERATIVE MONTHS. METHODS AND RESULTS: PATIENTS WHO UNDERWENT OPEN AORTIC RECONSTRUCTION FOR EITHER ANEURYSMAL OR OCCLUSIVE DISEASE BETWEEN 2004 TO 2018 USING BOTH EPTFE AND POLYESTER GRAFTS, AND WHO HAD FOLLOW-UP IMAGING 3 MONTHS OR MORE AFTER REPAIR, WERE INCLUDED. OF THE 140 PATIENTS INCLUDED IN THE STUDY, 88 WERE TREATED WITH EPTFE GRAFTS. IT WAS DETERMINED THAT PGH DEVELOPED MORE FREQUENTLY IN PATIENTS WITH EPTFE GRAFTS (21/88) COMPARED TO THOSE WITH POLYESTER GRAFTS. OF THE 21 PATIENTS TREATED WITH AN EPTFE GRAFT AND WHO DEVELOPED A SUBSEQUENT PGH, 4 PRESENTED WITH PGH-RELATED SYMPTOMS. ALL PGHS DEVELOPED AFTER ABDOMINAL AORTIC ANEURYSM REPAIRS. IT WAS HYPOTHESIZED THAT INTRINSIC GRAFT POROSITY MAY ALSO CONTRIBUTE TO PGH FORMATION. ALL EPTFE GRAFTS WERE MANUFACTURED BY W.L. GORE & ASSOCIATES (BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT). OF THE PATIENTS TREATED WITH AN EPTFE, 58 WERE MALE AND 30 WERE FEMALE. THE MEAN AGE WAS 68.6 ± 10.2 YEARS. IT WAS CONCLUDED THAT PGH IS A COMPLICATION AFTER OPEN AORTIC RECONSTRUCTION FOR ANEURYSMAL DISEASE, AND THAT PATIENT EDUCATION AND CLOSE SURVEILLANCE IS WARRANTED. IT WAS DETERMINED THAT PATIENTS WHO DEVELOPED PGH HAD LARGER ANEURYSMS, MORE OFTEN RECEIVED EPTFE GRAFTS, HAD LARGER GRAFT DIAMETERS, AND HAD BIFURCATED GRAFTS. MANUFACTURER'S DEVICE MODIFICATION IS DEEMED NECESSARY. PATIENT (B)(6) - ONE PATIENT WHO HAD UNDERGONE AAA REPAIR IN 2004 WITH A 20X10 EPTFE GRAFT WAS DETECTED TO HAVE AN ASYMPTOMATIC 11.0 CM PGH AT A 5-YEAR ROUTINE FOLLOW-UP CTA. NO INTERVENTION WAS PLANNED AND THE PATIENT WAS LOST TO FOLLOW-UP UNTIL 5 YEARS LATER WHEN HE PRESENTED WITH BILATERAL LOWER EXTREMITY CLAUDICATION SYMPTOMS AND UNDERWENT BILATERAL ILIAC STENTING; AT THAT TIME, A TINY PROXIMAL ANASTOMOTIC PSEUDOANEURYSM WAS NOTED. THE PATIENT HAD A FOLLOW-UP CTA 2 YEARS LATER (12 YEARS AFTER THE INDEX OPERATION) AND PGH WAS NOTED TO HAVE INCREASED IN SIZE TO 13.6 11.8 CM; THE PSEUDOANEURYSM WAS NOTED TO BE STABLE. CONSERVATIVE THERAPY WAS ELECTED AND THE PSEUDOANEURYSM EVENTUALLY RUPTURED INTO THE PGH AT 13.6 YEARS. THE PATIENT WAS TREATED WITH A RESECTION AND PARTIAL REPLACEMENT OF THE EPTFE GRAFT WITH A POLYESTER GRAFT WITHOUT RECURRENCE OF THE PGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361204 BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R MEDICATION: CREATININE.