BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 2398671 · Received January 5, 2012

    Report

    Report Number
    1063481-2012-00002
    Event Type
    Death
    Date Received
    January 5, 2012
    Date of Event
    December 19, 2011
    Report Date
    March 30, 2012
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, AN RV-PA CONDUIT PLACEMENT PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. APPROXIMATELY ONE HOUR AFTER SURGERY, THE PATIENT DISPLAYED SIGNS OF CARDIAC TAMPONADE. THE PATIENT WAS RETURNED TO SURGERY FOR CONTROL OF SUSPECTED BLEEDING. CPR WAS IN PROGRESS. THERE WAS A TEAR FOUND IN THE GRAFT. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND THE SITE WAS REPAIRED WITH PATCH MATERIAL. HOWEVER, THE PATIENT DID NOT RECOVER. THE TEAR WAS NOTED IN THE PROXIMAL MUSCULAR PORTION OF CONDUIT. THE HOSPITAL ALSO INDICATED THAT THE GRAFT APPEARANCE AND TEXTURE WERE THE SAME AS USUAL, OTHER THAN, A SLIGHT YELLOW COLOR. A REVIEW OF THE PROCESSING RECORDS INDICATES THAT THE ALLOGRAFT WAS PROCESSED ACCORDING TO ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE DONOR RECORD SHOWED THAT THE DONOR HAD NO PRE-EXISTING MEDICAL CONDITIONS, SUCH AS CONNECTIVE TISSUE DISORDERS, INFECTION, CARDIAC DISEASE, ETC., THAT MAY ADVERSELY AFFECT TISSUE QUALITY. THE DONOR RECORD WAS FOUND TO MEET ALL ACCEPTANCE CRITERIA SUCH AS PREPROCESSING AND POST-PROCESSING CULTURES, WARM AND TOTAL ISCHEMIC TIMES, RECOVERY PARAMETERS, AND ACCEPTABLE ANATOMIC SPECIFICATIONS. THE PRECISE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. NO EXPLANTED TISSUE WAS RETURNED TO CRYOLIFE FOR EXAMINATION. THE "YELLOWISH COLOR" NOTED BY THE SURGEON IS BELIEVED TO BE WITHIN THE NORMAL VARIATION OF THE SYNERGRAFT PROCESSED HUMAN TISSUE AND IS LIKELY NOT SIGNIFICANT. POSSIBLE CAUSES OF THE REPORTED EVENT MAY INCLUDE, BUT ARE NOT LIMITED TO, UNDETECTED MICROFRACTURES, SURGICAL TECHNIQUE, UNRECOGNIZED MICROTRAUMA, AND MISHANDLING OF THE ALLOGRAFT WHILE IN THE FROZEN STATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, AN RV-PA CONDUIT PLACEMENT PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. APPROXIMATELY ONE HOUR AFTER SURGERY, THE PATIENT DISPLAYED SIGNS OF CARDIAC TAMPONADE. CPR WAS ADMINISTERED AND THE PATIENT WAS RETURNED TO SURGERY FOR CONTROL OF SUSPECTED BLEEDING. DURING SURGERY, A TEAR WAS FOUND IN THE PROXIMAL MUSCULAR PORTION OF THE CONDUIT OF THE ALLOGRAFT. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND THE SITE WAS REPAIRED WITH PATCH MATERIAL. HOWEVER, THE PATIENT DID NOT RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY VALVE & CONDUIT SG HUMAN HEART ALLOGRAFT MIE CRYOLIFE, INC. SGPV00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death