BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD HEMABRIDGE WOVEN VASCULAR PROSTHESIS

    MDR report key: 823920 · Received March 1, 2007

    Report

    Report Number
    1640201-2007-00005
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    December 1, 2006
    Report Date
    January 24, 2007
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFO CONTAINED IN THIS REPORT WAS PROVIDED BY THE MFR. NO FACILITY NUMBER HAS BEEN ASSIGNED TO THIS REPORT. NO DEVICE EVALUATION WAS PERFORMED SINCE THE GRAFT REMAINED IMPLANTED IN PT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, NO ANOMALY WAS FOUND IN THE COLLAGEN COATING RECORDS OR IN THE SEWING RECORDS; NO PRODUCT WAS REJECTED AFTER SEWING INSPECTION OR FOR COLLAGEN COATING DEFECTS. TWO PRODUCTS COATED THE SAME DAY THAN THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING. FOR THESE TWO PRODUCTS, TESTS RESULTS INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. NO LEAKAGE WAS OBSERVED AT THE SEWN SEAMS. NO CONCLUSION CAN BE DRAWN. HOWEVER, IT WAS REPORTED THAT PHYSICIAN SUSPECTED BLEEDING TO BE ATTRIBUTED TO A POTENTIAL FAILURE IN SUTURING DURING SURGERY.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ASCENDING AORTA REPLACEMENT PROCEDURE IN 2006. DURING SURGERY, BLOOD LEAKING WAS EVIDENCED FROM THE BASE OF THE BRANCH OF THE GRAFT. HEMOSTASIS WAS OBTAINED BY COMPRESSION OF THE BLEEDING SITE WITH GAUZE DRESSING. NO HEMOSTATIC AGENT WAS USED. IT WAS ALSO REPORTED THE HEMOSTASIS RESULTED IN THE PROLONGATION OF THE PROCEDURE AND OF THE PT OXYGENATION. GRAFT REMAINED HOWEVER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD HEMABRIDGE WOVEN VASCULAR PROSTHESIS COLLAGEN COATED WOVEN VASCULAR PROSTHESIS DSY INTERVASCULAR HEW2810BRIDGE 06B02

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention