BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE VALSALVA

    MDR report key: 2452240 · Received February 10, 2012

    Report

    Report Number
    9612515-2012-00002
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    December 20, 2012
    Report Date
    January 16, 2017
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K013022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE EXPLANTED DEVICE IS BEING MADE AVAILABLE FOR INVESTIGATION. (B)(6) HOSPITAL HAS APPOINTED AN OUTSIDE REVIEWER TO INSPECT THE DEVICE, AN INDEPENDENT REVIEWER WILL ATTEND ON BEHALF OF VASCUTEK. A PROVISIONAL DATE WAS SET FOR THIS REVIEW (B)(4). A NEW DATE OF (B)(4) HAS NOW BEEN SET TO ACCOMMODATE VASCUTEK'S REPRESENTATIVE. THE FOLLOWING PERSONS WILL BE ATTENDING (B)(4). THE ACTIONS ARE AS LISTED. BEGIN AT VASCUTEK LTD. (OR SUITABLE (B)(6) LABORATORY) AT 11:00 AM, IN THE PRESENCE OF: (B)(4) PERFORM A GROSS INSPECTION UNDER THE MICROSCOPE. TAKE PHOTOGRAPHS AND DEVELOP NAMING/NUMBERING SYSTEM FOR SUTURES AND GRAFT. EXPLANT THE GRAFT AT THE AORTIC VALVE WHILE MAINTAINING THE SUTURES AROUND THE GRAFT. CONTINUE MICROSCOPIC INSPECTION WITH EXPLANTED GRAFT AND SURROUNDING TISSUE. DISCUSSION BETWEEN (B)(4). DISCUSS SUBSEQUENT TEST METHODOLOGY (SEM), IF INDICATED. THE LABORATORY SETUP AT VASCUTEK LTD (OR (B)(6) LABORATORY) SHOULD CONTAIN THE FOLLOWING: STEREOMICROSCOPE WITH MAGNIFICATION UP TO APPROX 60X AND HIGH RESOLUTION DIGITAL PHOTOGRAPHIC CAPABILITIES (PHOTO TUBE WITH CAMERA ATTACHED). EXTERNAL DISPLAY MONITOR CONNECTED TO THE DIGITAL CAMERA. LIGHT SOURCE TO BE USED WITH MICROSCOPE. PERSONAL PROTECTIVE EQUIPMENT FOR HANDLING BIOLOGICAL MATERIAL. PROPER DISPOSAL AND CLEANING SUPPLIES FOR BIOLOGICAL MATERIAL. SCISSORS, NEEDLES, AND OTHER DISSECTING EQUIPMENT TO BE USED WITH THE MICROSCOPE. WE REQUESTED AND RECEIVED AND ADVERSE EVENT FORM, BUT STILL NEED TO REQUEST FURTHER INFO. WE ARE TRYING TO CONTACT THE IMPLANTING SURGEON TO OBTAIN THE FOLLOWING INFO: CAUSE OF TEAR IN AORTA; DID THE TEAR EXTEND INTO THE GRAFT FABRIC; AFTER THE INDEPENDENT INSPECTION HAS TAKEN PLACE, CAN WE REQUEST THAT THE GRAFT BE RETURNED TO VASCUTEK FOR INVESTIGATION; CAN THE CAUSE OF DEATH (PRIMARY AND SECONDARY) AS DESCRIBED IN THE AUTOPSY REPORT BE PROVIDED? CONCLUSION: VASCUTEK FIND OUT AS MUCH INFO AS POSSIBLE AND PRESENT THIS IN OUR FINAL REPORT. GELWEAVE VALSALVA IS INTENDED FOR REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE ABDOMEN AND THORACIC AORTA IN CASES OF ANEURYSM, DISSECTION OR COARCTATION. THE CONFIGURATION MIMICS THE GEOMETRY OF THE SINUSES OF VALSALVA. THE GELWEAVE GRAFT WAS FIRST APPROVED IN EUROPE IN 1995, AND IN THE USA IN 1995 (K952293). THE GELWEAVE VALSALVA GRAFT WAS FIRST APPROVED IN EUROPE IN 2001 AND IN THE USA IN 2002 (K013022). THIS EVENT WAS BROUGHT TO VASCUTEK'S ATTENTION ON (B)(4) 2012 WHEN VASCUTEK BECAME OF (B)(4) ENQUIRY TO (B)(4) OF TERUMO MEDICAL, THE MEDWATCH FORM COMPLETED BY THE USER WAS ALSO RECEIVED AT THIS TIME. REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    PT WITH CONGENITAL HEART, RE-DO STERNOTOMY, LEFT OPERATING ROOM HEMODYNAMICALLY STABLE, WENT TO PCTU (PEDIATRIC CARDIO-THORACIC UNIT). BEGAN BLEEDING, TAKEN BACK TO OPERATING ROOM. THE BLEEDING WAS NOTED TO BE COMING FROM A TEAR IN THE AORTA JUST AT THE LEVEL OF THE ANASTOMOSIS BETWEEN THE CONDUIT AND THE ASCENDING AORTA. THE BLEEDING WAS NOT CONTROLLABLE AND THE ORIGINAL TEAR EXTENDED SIGNIFICANTLY AND MOST LIKELY INVOLVED THE ENTIRE POSTERIOR PORTION OF THE GRAFT. UNABLE TO CONTROL BLEEDING. PT EXPIRED. PRELIMINARY AUTOPSY SHOWED 3MM HOLE IN AORTIC GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE VALSALVA VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA 124412 3572

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Death