BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED ULTRATHIN

    MDR report key: 7568305 · Received June 5, 2018

    Report

    Report Number
    1640201-2018-00015
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    May 4, 2018
    Report Date
    September 27, 2018
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401001270
    PMA / PMN Number
    K983819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (3331/213) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN TEXTILE RECORDS. MECHANICAL RESISTANCE TESTS PERFORMED ON TEXTILE DISPLAYED RESULTS AND VALUES WELL WITHIN PRODUCT SPECIFICATIONS. (10/180) THE INVOLVED DEVICE WAS RETURNED TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE MACROSCOPIC ANALYSIS REVEALED PRESENCE OF TWO LARGE HOLES OF 1X0,8CM AND 3X1CM ON THE GRAFT FOR WHICH THE MARGINS, EXHIBITING SIGNS OF FILAMENT FRAYING, EVOKED GRAFT TEARS. (4109/213) THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. (4315) THE OUTCOME OF OUR INVESTIGATION WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. PRESENCE OF TWO LARGE HOLES WAS CONFIRMED, PROBABLY AS A RESULT OF MECHANICAL FORCE WHOSE CAUSE REMAINS UNKNOWN. IN ADDITION, THE CORPORATE MEDICAL OFFICER THOROUGHLY REVIEWED THE CASE, IN COLLABORATION WITH THE INVOLVED SURGEON. THEY AGREED THAT THE HOLES APPEAR TO BE DUE TO MECHANICAL FORCE BUT THEY WERE UNABLE TO COME TO ANY RATIONALE FOR THE FINDINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS (TEXTILE, GREIGE PREP AND MANUFACTURING RECORD), INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES. (B)(4). THE INVOLVED DEVICE WAS RETURNED TO AN EXTERNAL AND INDEPENDANT LABORATORY FOR MACROSCOPIC OBSERVATION. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN "EXPLANTATION OF GRAFT INTERGARD ULTRATHIN 8X40 IMPLANTED DURING A PRECEDENT SURGERY (IN DATE (B)(6) 2012) FOR RIGHT POPLITEAL ARTERY REPLACEMENT: DURING THIS SECOND SURGERY, IT WAS POSSIBLE TO SEE TWO BIG HOLES IN THE WALL OF THE PROSTHESIS. THERE WAS NO SIGN OF INFECTION." ADDITIONAL INFORMATION INDICATED THAT "THE MOTIVATION OF THE 2ND SURGERY IS THE PRESENCE OF A 5 CM PSEUDO-ANEURYSM OF POPLITEAL ARTERY, CAUSED BY LACERATION OF THE PROSTHESIS AND CONFIRMED BY CT ANGIOGRAPHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411380 INTERGARD KNITTED ULTRATHIN VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS IGKUT0008-40 11E05 00384401001270

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention