BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED

    MDR report key: 6119998 · Received November 22, 2016

    Report

    Report Number
    1640201-2016-00034
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 26, 2016
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401000488
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (10/3287/213) ONE REMAINING FRAGMENT OF THE COMPLAINT DEVICE WAS SENT TO AN OUTSIDE LABORATORY FOR MACROSCOPIC AND SCANNING ELECTRON MICROSCOPY (SEM) EVALUATION. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE PRESENCE OF ANY STRUCTURAL ABNORMALITY VISIBLE ON THE EXTERNAL SIDE OF THE RETURNED FRAGMENT AND TO EVALUATE THE PRESENCE OF COLLAGEN MATERIAL. THE SEM ANALYSIS POINTED OUT A MASSIVE COLLAGEN INFILTRATION THROUGH THE TEXTILE STRUCTURE EVEN THOUGH A POST-SAMPLING FUNGAL AND MICROBIAL CONTAMINATION WAS NOTICED (RELATED TO THE CONDITIONS OF STORAGE AND TRANSPORTATION). NO SIGNIFICANT ABNORMALITY SUCH AS TEARS, LOSS OF TEXTILE COHESION, HOLES OR SIGNS OF CUT WERE OBSERVED. THE SEM ANALYSIS CORROBORATED THE MACROSCOPIC ANALYSIS. (67) NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFORMATION AND THE PRODUCT TESTING PERFORMED WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. ONE RETENTION SAMPLE COATED ON THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING AT 120MMHG AS PER ISO (B)(4). THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. THE INVESTIGATION IS STILL ON-GOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ABDOMINAL AORTIC ANEURYSM SURGERY PERFORMED ON (B)(6) 2016, IT WAS REPORTED A BLOOD LEAK FROM THE BIFURCATION OF THE MAIN SEGMENT. LEG BRANCH WAS CUT AND CENTER AREA WAS USED FOR STRAIGHT PIPE TO CONTINUE THE SURGERY. NO ADVERSE CONSEQUENCE FOR THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771729 INTERGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS IGK1608 16A21 00384401000488

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention