BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 8403133 · Received March 8, 2019

    Report

    Report Number
    9612515-2019-00004
    Event Type
    Death
    Date Received
    March 8, 2019
    Date of Event
    November 27, 2018
    Report Date
    March 20, 2019
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881106724
    PMA / PMN Number
    K040829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT CODE: 3218 - MICROBIAL CONTAMINATION. CONCLUSION CODE: 4310 - CAUSE CANNOT BE TRACED TO DEVICE, 4315 - CAUSE NOT ESTABLISHED. GRAFT WAS NOT PROVIDED BY THE HOSPITAL FOR FURTHER ANALYSIS. HOWEVER, TESTING WAS CARRIED OUT AT UNIVERSITY HOSPITAL BASEL DEPARTMENT OF INFECTIOLOGY & HOSPITAL HYGIENE. CULTURALLY NO MYCOBACTERIA COULD BE DETECTED; HOWEVER, THROUGH PCR BASED DETECTION METHOD, MYCOBACTERIUM CHELONAE WAS IDENTIFIED. THE AUTOPSY REPORT CONFIRMED THAT THE INFECTION COULD NOT BE PROVEN AND INDICATED A POTENTIAL ALLERGIC REACTION TO THE BOVINE MATERIAL OF THE BIOINTEGRAL SURGICAL AORTIC VALVE, WHICH WAS IMPLANTED WITH THE VASCUTEK LTD GELWEAVE GRAFT. VASCUTEK LTD STERILISATION RECORDS SHOWED THAT ALL PARAMETERS WERE MET DURING PRODUCT STERILISATION USING ETHYLENE OXIDE (ETO). A LITERATURE REVIEW WAS CONDUCTED AND IT WAS FOUND THAT ETHYLENE OXIDE IS EFFECTIVE IN KILLING MYCOBACTERIA (INTERNET JOURNAL OF MEDICAL UPDATE. 2017 JULY; 12 (2): 1-3). FURTHER ACTION IS NOT PLANNED; HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK LTD CONSIDER THIS CASE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # 9612515-2019-00004 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF MANUFACTURING AND STERILISATION RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO THE INTENDED SPECIFICATION. STERILISATION RECORDS SHOWED THAT ALL PARAMETERS WERE MET DURING PRODUCT STERILISATION. CLEANROOM (CLASS 7) ENVIRONMENTAL REVIEW DURING PERIOD OF NOVEMBER AND DECEMBER 2015, WHEN COMPLAINT GRAFT WAS MANUFACTURED, WAS CARRIED OUT. NOVEMBER AND DECEMBER BIOBURDEN RESULTS WERE ACCEPTABLE, AND NO UNUSUAL ISOLATES WERE RECOVERED. A FIVE-YEAR REVIEW OF SIMILAR EVENTS FOR DEATH AND INFECTION IN WOVEN GRAFTS GAVE A LOW OCCURRENCE RATE OF 0.001% (COMPLAINTS V SALES). THERE HAVE BEEN NO SIMILAR COMPLAINTS RECEIVED FROM OTHER UNITS OF THE SAME BATCH. BATCH CONSISTED OF THREE UNITS, REMAINING TWO UNITS WERE SUCCESSFULLY IMPLANTED, WITH NO ISSUES IDENTIFIED. VASCUTEK LTD REQUESTED ADDITIONAL INFORMATION FROM THE HOSPITAL TO ASSIST WITH FURTHER INVESTIGATION AND WILL SHARE RESULTS OF INVESTIGATION IN FOLLOW UP / FINAL REPORT.

    Description of Event or Problem · 1

    DESCRIPTION NARRATIVE IS A TRANSLATION OF (B)(4) (MEDICAL FACILITY REFERENCE NUMBER) AND WILL BE UPDATED WHEN EVENT INTAKE FORM IS RECEIVED FROM THE HOSPITAL. THE INCIDENT HAS BEEN DESCRIBED TO VASCUTEK LTD AS; OUTBREAK OF THE BIO-COMPOSITE GRAFT (INITIAL IMPLANT ON (B)(6) 2017 IN AORTIC DISSECTION TYPE A) WITH LARGE PSEUDO-ANEURYSM POSSIBLY IN CASE OF INFECTION WITH MYCOBACTERIUM CHELONAE (PREVIOUSLY NO GROWTH, ACID-FAST RODS IN SEVERAL DIRECT PREPARATIONS, METAGENOMIC DETECTION OF M. CHELONAE - EXPERIMENTAL METHOD USED). PATIENT DIED ON (B)(6) 2018 IN PERIPROSTHETIC INSUFFICIENCY AFTER RE-COMPOSITE GRAFT INSERTION ON (B)(6) 2018. HEMORRHAGIC AND CARDIOGENIC SHOCK WITH MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198091 GELWEAVE GELWEAVE ANTE FLO DSY VASCUTEK LTD 373066 8361 05037881106724

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death