BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 5409724 · Received February 4, 2016

    Report

    Report Number
    9612515-2016-00003
    Event Type
    Death
    Date Received
    February 4, 2016
    Date of Event
    December 10, 2015
    Report Date
    May 24, 2016
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    PMA / PMN Number
    K090987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURERS NARRATIVE METHOD CODES: ACTUAL DEVICE INVESTIGATED - EXPLANTED DEVICE RETURNED TO VASCUTEK LTD. AND INVESTIGATED. FLOW TESTING - GRAFT POROSITY WITH WATER TESTED. VISUAL INSPECTION - VISUAL INSPECTION OF RETURNED GRAFT CARRIED OUT BOTH PRE AND POST DECONTAMINATION. PHOTOGRAPHIC INSPECTION CARRIED OUT - IMAGES OF PRE AND POST DECONTAMINATION TAKEN. ELECTRON MICROSCOPY - IMAGES TAKEN USING SCANNING ELECTRON MICROSCOPE (SEM) TO DOCUMENT GROSS AND FINE STRUCTURE OF DECONTAMINATED GRAFT. RESULT CODES: NO FAILURE DETECTED - POROSITY TESTING WITH WATER WAS CARRIED OUT AND RESULTS WERE STILL BELOW MAXIMUM ACCEPTANCE CRITERIA. MECHANICAL PROBLEM - INITIAL LEAKAGE BELIEVED TO BE CAUSED BY WEAR ON GRAFT FROM CONTACT WITH ABRASIVE EDGE OF CUT STERNUM. FRICTION PROBLEM - INITIAL DAMAGE TO GRAFT CAUSED BY FRICTION FROM CUT EDGE OF STERNUM AGAINST GRAFT SURFACE. CONCLUSION CODE: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT - IT IS BELIEVED THAT THE POSITION OF THE GRAFT DURING THE INITIAL PROCEDURE LED TO THE FIRST HOLE IN GRAFT FROM CONTACT WITH CUT EDGE OF STERNUM. IT IS BELIEVED THAT THE SUBSEQUENT HOLES AND LEAKAGE MAY HAVE BEEN DUE DAMAGE CAUSE DURING INTERVENTION TO REPAIR INITIAL DAMAGE. IN CONCLUSION, NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FROM INVESTIGATION AND TESTING CARRIED OUT AT VASCUTEK FOR THE LEAKAGE SEEN. VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED HOWEVER THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO EVENT - DEATH - VASCUTEK NOTIFIED ON 15TH APRIL 2016 THAT PATIENT HAD DIED OF ENCEPHALORRHAGIA ON (B)(6) 2016. VASCUTEK WAS ALSO INFORMED THAT A 3RD INTERVENTION TOOK PLACE ON THE (B)(6) 2016 FOR LEAKAGE. EXPLANT DATE - GRAFT WAS EXPLANTED AFTER PATIENT DEATH ON (B)(6) 2016. DEVICE AVAILABLE FOR EVALUATION- DEVICE HAS BEEN EXPLANTED AND WAS RETURNED TO VASCUTEK ON 27TH APRIL FOR EVALUATION BUT HAS NOT YET BEGUN. (B)(4). METHOD - ACTUAL DEVICE TO BE EVALUATED BUT NOT YET BEGUN. RESULTS - RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION - CONCLUSION NOT YET AVAILABLE AS EVALUATION NOT YET BEGUN. VASCUTEK WILL REPORT RESULTS OF INVESTIGATION WITHIN 30 DAYS OF RECEIPT OF EXPLANTED GRAFT.

    Additional Manufacturer Narrative · 1

    DEVICE REPAIRED USING SUTURE AND HYDROFIT AND REMAINS IMPLANTED. (B)(4). ON THIS BASIS VASCUTEK NOW CONSIDERS THIS COMPLAINT CLOSED. HOWEVER THIS ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS ACTION WILL BE TAKEN AT THAT TIME.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS A 2ND FOLLOW UP/ FINAL REPORT FOR MFR REPORT # 9612515-2016-00003 TO PROVIDE ADDITIONAL INFORMATION REGARDING INVESTIGATION OF RETURNED EXPLANTED GRAFT FROM PATIENT WHO DIED ON (B)(6) 2016 DUE TO ENCEPHALORRHAGIA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP 1 FOR MFR REPORT # 9612515-2016-00003 TO PROVIDE ADDITIONAL INFORMATION REGARDING A 3RD GRAFT LEAK WHICH WAS FOUND ON (B)(6) 2016 AND REPAIRED AND REGARDING PATIENT DEATH ON (B)(6) DUE TO ENCEPHALORRHAGIA. VASCUTEK BECAME AWARE OF THE ADDITIONAL INFORMATION ON 15TH APRIL 2016. THE GRAFT WAS EXPLANTED AND HAS BEEN RECEIVED BY VASCUTEK ON 27TH APR-16 FOR INVESTIGATION.

    Description of Event or Problem · 1

    BLOOD LEAK FROM A GELWEAVE TRIFUCATE THE PATIENT UNDERWENT ASCENDING AORTA REPLACEMENT AND A VALVE REPLACEMENT ON (B)(6) 2015. PATIENT IS NOT ON DIALYSIS WITH NO INFECTION. ON (B)(6) 2015, THE INVOLVED GELWEAVE TRIFUCATE WAS USED FOR TOTAL DEBRANCHING AND STENT GRAFTING. ON (B)(6) 2015, THE PATIENT DEVELOPED AN ABNORMAL BULGE IN THE CHEST AND WAS CT-EXAMINED. IMMEDIATELY HER HEART WAS RE-OPENED AND BLEEDING WAS FOUND ON THE MAIN BODY OF THE INVOLVED GELWEAVE. A STITCH WAS GIVEN TO THE GRAFT. THE GRAFT MAY HAVE BEEN WORN OUT BY COMING INTO CONTACT WITH THE REMAINING PART OF THE CUT STERNUM. ON (B)(6) 2015, ANOTHER BULGE WAS NOTED WITH BLEEDING AT THE OPENING OF THE WOUND. IMMEDIATELY AFTER CT-EXAMINATION, HER CHEST WAS RE-OPENED AGAIN. BLEEDING WAS FOUND AT THE SEGMENT A STITCH HAD BEEN GIVEN PREVIOUSLY, AT A LONGITUDINAL CRACK APPROX. 3MM IN LENGTH AND A PIN-HOLE LIKE RUPTURE ON ANOTHER BODY PART. TO ARREST THE BLEEDING, DR. (B)(6) THEM WITH A NEEDLE AND APPLIED HYDROFIT TO THEM TO COAT THEM WITH IT. THE NEWLY FOUND CRACK AND HOLE ARE NOT LOCATED TO THE SEGMENT WITH WHICH THE STERNUM CAME INTO CONTACT OR TO WHICH SOME PRESSURE IS APPLIED. DR. DID NOT USE AN AIR-NEEDLE. HE USED NORMAL FORCEPS DEDICATED FOR USE ON A BLOOD VESSEL. THE PATIENT IS STILL IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69081 GELWEAVE GELWEAVE GELATIN IMPREGNATED WOVEN VASCULAR PROSTHESIS DSY VASCUTEK LTD GELWEAVE TRIFURCATE 347024

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| R