BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERGARD WOVEN VASCULAR GRAFT

    MDR report key: 2195301 · Received July 1, 2011

    Report

    Report Number
    1640201-2011-00015
    Event Type
    Other
    Date Received
    July 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K984294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT EVAL WAS PERFORMED SINCE THE GRAFT REMAINED IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, IT SHOULD BE NOTED THAT A QC INSPECTION, INCLUDING LENGTH VERIFICATION, IS PERFORMED ON EVERY FINISHED GRAFT. THEREFORE, IT IS HIGHLY LIKELY THAT THE GRAFT WAS CUT AT THE RIGHT LENGTH. WOVEN GRAFTS WITH A 22-MM DIAMETER ARE ONLY AVAILABLE IN LENGTHS OF 15 CM, 30 CM, AND 60 CM. THE REPORTED 20.8 CM LENGTH DOES NOT CORRESPOND TO ANY OF THESE AND IS THEREFORE ATTRIBUTED TO DIFFERENT MEASURING CONDITIONS AT THE HOSPITAL. THE HYPOTHESIS OF AN INVERSION WITH A 15 CM WOVEN GRAFT IS REJECTED SINCE A 15 CM WOVEN GRAFT WOULD BE TOTALLY COMPATIBLE WITH THE REPORTED DISTANCE BETWEEN DISTAL AND PROXIMAL ANASTOMOSES. AN INVERSION WITH A 60 CM WOVEN GRAFT WOULD NOT LEAD TO THE REPORTED EVENT. NO CONCLUSION CAN BE DRAWN. HOWEVER, THE INVESTIGATION PERFORMED WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE. NO ADD'L INFO ABOUT THE CURRENT STATUS OF THE PT, THE POTENTIAL PERSISTENCE OF A NEUROLOGICAL DEFICIENCY AND THE DATE OF IMPLANTATION COULD BE OBTAINED FROM THE INSTITUTION AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN AORTIC ANEURYSM SURGICAL PROCEDURE INVOLVING THE ENTIRE THORACIC AORTA. FOR THIS KIND OF PROCEDURE, THE VASCULAR PROSTHESIS IS ANASTOMOSED DISTALLY TO THE SUBCLAVIAN ARTERY TO PERFORM A COMPLETE REPLACEMENT OF THE AORTA. THEN, THE OTHER END OF THE PROSTHESIS, WHICH HAS EARLIER BEEN DRAWN THROUGH THE DESCENDING AORTA WITH THE AID OF A GUIDE WIRE, IS ANASTOMOSED IN THE AREA OF THE THORACO-ABDOMINAL TRANSITION. IN ORDER TO ENSURE BLOOD CIRCULATION THROUGH THE DISTAL INTERCOSTAL VESSELS, AN OPENING IS CUT INTO PROSTHESIS. IT WAS REPORTED THAT DURING THE OPERATION IN QUESTION, IT WAS VERY DIFFICULT TO PULL THE EXISTING PROSTHESIS FROM THE DISTAL LUMEN. THE MADE OPENING DID NOT LEAD TO AN EFFECTIVE BLOOD CIRCULATION OF THE FALSE LUMEN. IT WAS REPORTED THAT THIS WAS PROBABLY DUE TO THE FACT THAT THE PROSTHESIS WAS PULLED FAIRLY TAUT TO THE DORSAL AORTIC WALL. THIS RESULTED IN NEUROLOGICAL COMPLICATIONS FOR THE PT. IT WAS ALSO REPORTED THAT THE LENGTH OF THE STRETCHED PROSTHESIS AS SHOWN ON THE CONTROL CD WAS 20.8 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD WOVEN VASCULAR GRAFT DSY INTERVASCULAR IGW0022-30 08L27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other