BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PROPATEN® VASCULAR GRAFT

    MDR report key: 11850534 · Received May 19, 2021

    Report

    Report Number
    2017233-2021-02018
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    March 30, 2021
    Report Date
    December 10, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS ADDED OR UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED: A4: PATIENT WEIGHT - 120 LBS. B5: EVENT DESCRIPTION. B7: MEDICAL HISTORY - DIABETES, HYPERTENSION, A-FIB, PAD. D4: CATALOG NUMBER, SERIAL NUMBER, EXPIRATION DATE. H4: DEVICE MANUFACTURE DATE. H6: IMPACT CODE - CODE 4642 ADDED. H6: MEDICAL DEVICE PROBLEM CODE - UPDATED TO CODE 4008 . H6: COMPONENT CODE - CODE 525 ADDED. H6: INVESTIGATION FINDINGS - UPDATED TO CODE 213 G4: PMA/510(K) NUMBER CORRECTED TO K062161.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE VIA MEDWATCH: ON (B)(6), 2021, THE PATIENT UNDERWENT BILATERAL FEMORAL ENDARTERECTOMIES AND A RIGHT AXILLARY TO FEMORAL BYPASS UTILIZING A GORE® PROPATEN® VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6), 2021. ON (B)(6), 2021, THE PATIENT NOTED SWELLING AND CHEST PAIN AND UNDERWENT REINTERVENTION. AN ANGIOGRAM REVEALED A LARGE RIGHT CHEST WALL HEMATOMA WITH ACTIVE BLEEDING, OCCLUSION OF THE PATIENTS AXILLARY FEMORAL AND FEM-FEM BYPASS GRAFTS, CHRONIC OCCLUSION OF THE INFERIOR ASPECT OF THE ABDOMINAL AORTA, PULMONARY EMPHYSEMA WITH NO ACUTE INTRATHORACIC ABNORMALITIES, AND NO ACUTE INTRA-ABNORMALITY. THE PATIENT RECEIVED A RIGHT AXILLARY CUTDOWN, WHICH CORRELATED ANATOMICALLY TO WHERE THERE WAS SUSPECTED GRAFT DISRUPTION. THE SURGEON DOCUMENTED THAT THERE WAS A LARGE TEAR IN THE MIDDLE OF THE GRAFT, BUT THE SUTURE LINE REMAINED COMPLETELY INTACT. THE PHYSICIAN WAS CONCERNED THAT IF THE GRAFT WAS REPAIRED THE PATIENT WOULD BLEED AGAIN, SO A STENT WAS PLACED ACROSS THE GRAFT TO ENSURE THERE WAS NO BLOOD FLOW THROUGH IT. THERE WERE NO PRE-EXISTING STENTS IN THE TREATMENT ZONE PRIOR TO IMPLANT OF THE GORE® PROPATEN® VASCULAR GRAFT. IT WAS REPORTED THAT THE PATIENT REQUIRED 10 UNITS OF BLOOD. THE PATIENT WAS DISCHARGED ON (B)(6), 2021 TO A NURSING HOME. THE PHYSICIAN DID NOT HAVE ANY INPUT ON HOW THE TEAR IN THE GRAFT COULD HAVE OCCURRED.

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE VIA MEDWATCH: ON (B)(6) 2021, THE PATIENT UNDERWENT BILATERAL FEMORAL ENDARTERECTOMIES AND A RIGHT AXILLARY TO FEMORAL BYPASS UTILIZING A GORE® PROPATEN® VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT NOTED SWELLING AND CHEST PAIN AND UNDERWENT REINTERVENTION. THE PATIENT RECEIVED A RIGHT AXILLARY CUTDOWN AND REPORTEDLY RECEIVED ADDITIONAL STENT(S). THE PHYSICIAN STATED THE SUTURE LINE REMAINED INTACT BUT REQUIRED 10 UNITS OF BLOOD. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747642 GORE® PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R