BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALBOGRAFT POLYESTER VASCULAR GRAFT

    MDR report key: 7123279 · Received December 15, 2017

    Report

    Report Number
    1220948-2017-00072
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 15, 2017
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MAL
    UDI-DI
    00840663103492
    PMA / PMN Number
    K103080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE GRAFT FOR EVALUATION. WHEN THE GRAFT WAS OBSERVED VISUALLY, WE DID NOT FIND ANY HOLES OR EXTERNAL DEFECTS IN THE GRAFT THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE PHYSICAL INCUBATION TEST (WHICH MEASURES HOW WELL THE COLLAGEN WAS IMPREGNATED INTO THE GRAFT) PREVIOUSLY PERFORMED ON A PORTION OF THIS EXACT COMPLAINT DEVICE WAS FOUND TO BE ACCEPTABLE. AN UNUSED GRAFT FROM THE SAME LOT NUMBER WAS TESTED FOR WATER PERMEABILITY DURING THIS INVESTIGATION. THE GRAFT PASSED THIS TEST. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES AT THE FINISHED GOOD, SUB ASSEMBLY OR RAW MATERIAL PHASE OF PRODUCTION THAT COULD BE RELATED TO THIS INCIDENT. OUR LOT DISTRIBUTION RECORDS SHOW THAT (B)(4) UNITS FROM THIS LOT HAVE BEEN SOLD. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FROM CUSTOMERS RELATED TO A SIMILAR ISSUE. WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT AND CONSIDER IT AN ISOLATED INCIDENT. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    ALBOGRAFT VASCULAR GRAFT AMC2010 LOT# 140129 SERIAL NUMBER (B)(4) WAS USED DURING OPEN AORTA ANEURISM TREATMENT. AFTER PERFORMING PROXIMAL ANASTOMOSIS, THE GRAFT START TO BLEED WHEN THE CLAMP WAS REMOVED. SO, ANOTHER LEMAITRE ALBOGRAFT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900296 ALBOGRAFT POLYESTER VASCULAR GRAFT VASCULAR PROSTHESIS MAL LEMAITRE VASCULAR, INC. 140129 00840663103492

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention