BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 9901633 · Received March 30, 2020

    Report

    Report Number
    2017233-2020-00220
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    October 7, 2019
    Report Date
    August 27, 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: H1. - TYPE OF REPORTABLE EVENT H6. - METHOD CODE 2 H6. - RESULTS CODE 2 H6. - CONCLUSIONS CODE 1 ADDITIONAL MANUFACTURER NARRATIVE: FURTHER REVIEW OF THE EVENT REVEALED THIS EVENT IS CONSIDERED A REPORTABLE SERIOUS INJURY. PREVIOUS SUPPLEMENTAL REPORTS STATING MEDWATCH RETRACTION ARE INVALID.

    Additional Manufacturer Narrative · 0

    H1. CORRECTED TYPE OF REPORTABLE EVENT (DEATH).

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES ADDITIONAL DEVICES REPORTED UNDER MFR REPORT NUMBERS:#2017233-2020-00219 AND #2017233-2020-00221.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G5. - COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H1. TYPE OF REPORTABLE EVENT. H6. CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: BOTH GORE PRODUCT SPECIALIST AND GORE OFFICE OF MEDICAL AFFAIRS AGREE THAT THE PATIENT'S DEATH DUE TO ASPIRATION IS NOT RELATED TO DEVICE PERFORMANCE OR PROCEDURE AND CLINICALLY INDEPENDENT FROM THE RECURRING PERIGRAFT HYGROMA FORMATION. THEREFORE THIS EVENT WILL BE CONSIDERED NON-REPORTABLE. MEDWATCH WERE SENT IN ERROR. ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH (AND SUPPLEMENTALS) WILL BE RETRACTED.

    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. THE FOLLOWING CORRECTIONS TO THE ARTICLE WERE REPORTED BY THE CORRESPONDING AUTHOR: THERE WERE 18 ASYMPTOMATIC PATIENTS (NOT 17), NONE OF WHOM UNDERWENT AN INTERVENTION. THERE WERE 22 PATIENTS WHO DEVELOPED PGH AFTER BEING TREATED WITH A GORE® DEVICE (NOT 21). 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) - A SECOND PATIENT (PREVIOUSLY IMPLANTED WITH A BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT 18 X 9) PRESENTED WITH ABDOMINAL PAIN RELATED TO THE PGH AT 52 POSTOPERATIVE MONTHS. A CT-GUIDED PERCUTANEOUS DRAINAGE OF THE 11.9 CM PGH WAS PERFORMED 2 DAYS LATER. THE DRAINAGE IMMEDIATELY RELIEVED HIS SYMPTOMS, BUT ULTIMATELY THE FLUID REAC­CUMULATED TO AN 11.6 CM HYGROMA 3 MONTHS LATER. AT THAT POINT, HE WAS STILL ASYMPTOMATIC BUT UNDERWENT PROPHYLACTIC MARSUPIALIZATION OF THE SAC. UNFORTUNATELY, THIS SUBSEQUENTLY RECURRED TO A 15.3-CM SAC BEFORE HE DIED OF ASPIRATION WHILE IN HOSPITAL AT 13.7 POSTOPERATIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363829 BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R MEDICATION: CREATININE