BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TO GORE-TEX® STRETCH VASCULAR GRAFT

    MDR report key: 12226080 · Received July 27, 2021

    Report

    Report Number
    3007284313-2021-01512
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    September 5, 2019
    Report Date
    June 3, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K904282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. G1: REPORTING CONTACT FIRST NAME UPDATED TO (B)(6). G1: REPORTING CONTACT LAST NAME UPDATED TO LAFAVE. G4: PMA/510(K)NUMBER, UPDATED TO K904282. D1/D2: BRAND NAME, UPDATED TO GORE-TEX® STRETCH VASCULAR GRAFT. D1/D2: PRODUCT CODE, UPDATED TO DSY. D1/D2: COMMON DEVICE NAME, UPDATED TO PROSTHESIS, VASCULAR GRAFT.

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT/DATE OF BIRTH: AS THE MEAN AGE OF THE PGH SUBGROUP WAS 68.2 YEARS OLD, THE PATIENT AGE HAS BEEN ESTIMATED AS 68 YEARS. PATIENT WEIGHT: UNAVAILABLE. DATE OF EVENT: AS THE DATE OF EVENT IS UNAVAILABLE, THE DATE OF EVENT HAS BEEN ESTIMATED AS THE ARTICLE PRESENTATION DATE: 5-SEP-2019. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: PRE-EXISTING CONDITIONS OF THE PGH SUBGROUP INCLUDE THOSE LISTED. DEVICE INFORMATION: THE DEVICE LOT/SERIAL NUMBER IS UNAVAILABLE. THEREFORE DEVICE INFORMATION REMAINS UNKNOWN. IF IMPLANTED, GIVE DATE: THE DATE OF DEVICE IMPLANT REMAINS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: UNAVAILABLE. DEVICE MANUFACTURE DATE: AS THE DEVICE LOT/SERIAL NUMBER IS UNAVAILABLE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: FREQUENCY OF PERIGRAFT HYGROMA AFTER OPEN AORTIC RECONSTRUCTION. BACKGROUND PERIGRAFT HYGROMA (PGH) IS A PERSISTENT COLLECTION OF STERILE FLUID AROUND A PROSTHETIC VASCULAR GRAFT. THE INCIDENCE OF PGH DEVELOPMENT AFTER AORTIC RECONSTRUCTION REMAINS POORLY DEFINED AND ITS CLINICAL RELEVANCE IS QUESTIONABLE. MOST PGHS ARE ASYMPTOMATIC AND DO NOT REQUIRE SURGICAL INTERVENTION. HOWEVER, WITH EXPANSION THESE FLUID COLLECTIONS CAN PRESENT SYMPTOMS OF ABDOMINAL PAIN, VOMITING, AND, IN WORST CASES, GRAFT COMPRESSION WITH THROMBOSIS OR RUPTURE OF THE PGH SAC. THIS STUDY WAS DESIGNED TO ESTABLISH THE INCIDENCE OF AND DETERMINE THE RISK FACTORS ASSOCIATED WITH PGH FORMATION AND ITS OUTCOMES. PATIENTS AND METHODS PATIENTS WHO UNDERWENT OPEN AORTIC RECONSTRUCTION FOR EITHER ANEURYSMAL OR OCCLUSIVE DISEASE WITH AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) OR POLYESTER GRAFT FROM 2004 TO 2018 WERE RETROSPECTIVELY REVIEWED (N=262). ONLY THOSE WHO HAD FOLLOW-UP IMAGING 3 OR MORE MONTHS AFTER REPAIR WERE INCLUDED. PATIENTS WITH MIXED GRAFT TYPES WERE EXCLUDED. PGH WAS DEFINED AS A PERIGRAFT FLUID COLLECTION OF 30 MM OR GREATER IN DIAMETER WITH A RADIODENSITY OF 30 OR FEWER HOUNSFIELD UNITS ON COMPUTED TOMOGRAPHY AT A MINIMUM OF 3 POSTOPERATIVE MONTHS. ANALYSIS WAS CONDUCTED BETWEEN PATIENTS WITH AND WITHOUT PGH. RESULTS ONE HUNDRED FORTY PATIENTS MET THE INCLUSION CRITERIA: 88 WERE TREATED WITH EPTFE (ALL MANUFACTURED BY W.L. GORE & ASSOCIATES) AND 52 WITH POLYESTER GRAFTS. TWENTY-THREE PATIENTS (16.4%) WERE FOUND TO HAVE RADIOLOGIC EVIDENCE OF PGH. PGH DEVELOPED MORE FREQUENTLY IN PATIENTS WITH EPTFE (21/88 [23.9%]) COMPARED WITH THOSE WITH POLYESTER GRAFTS (2/52 [3.8%]) (P= .002). ONE PATIENT PRESENTED WITH ABDOMINAL PAIN RELATED TO THE PGH AT 52 POSTOPERATIVE MONTHS. A CT-GUIDED PERCUTANEOUS DRAINAGE OF 350ML OF PERIAORTIC FLUID FROM 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
    1124844 TO GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.
    1124845 TO GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention