BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 1668789 · Received April 20, 2010

    Report

    Report Number
    2025587-2010-00038
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 7, 2008
    Report Date
    April 5, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT RETURN OF THE CONDUIT FOR EVALUATION, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE PERFORMANCE OF THE VALVE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVED CONDUIT, IMPLANTED 100 DAYS, WAS EXPLANTED WHEN SIGNIFICANT NARROWING OF BOTH PULMONARY ARTERIES AND RESIDUAL (CONGENITAL) VSD WAS FOUND. (ON DAY OF LIFE (DOL) 1, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR TRUNCUS REPAIR, PARTIAL CLOSURE OF THE ASD AND PLACEMENT OF A 12MM CONTEGRA.) POST-OP, THE PATIENT REQUIRED SIGNIFICANT INOTROPIC SUPPORT AND DEVELOPED JUNCTIONAL ECTOPIC TACHYCARDIA, TREATED WITH AMIODARONE. ON POST-OP DAY 4, EXTUBATION WAS UNSUCCESSFUL DUE TO RIGHT DIAPHRAGM PARALYSIS. ON POST-OP DAY 12, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A DIAPHRAGM PLACATION. EXTUBATION WAS SUCCESSFUL 3 DAYS LATER AND THE PATIENT WAS WEANED OFF ALL INOTROPIC SUPPORT. OVER THE NEXT FEW MONTHS, THE PATIENT REQUIRED RE-INTUBATION SEVERAL TIMES AS WELL AS PLACEMENT OF A GASTROSTOMY TUBE. ADDITIONALLY, THE PULMONARY ARTERIES WERE STENTED, BUT THIS CAUSED AN INCREASE IN THE SHUNTING ACROSS THE VSD AND RESULTED IN REINTUBATION. THE PATIENT WAS AGAIN TAKEN TO THE OPERATING ROOM ON DAY OF LIFE (DOL) 101 WHERE THE CONTEGRA WAS REPLACED WITH AN 11MM PULMONARY HOMOGRAFT, DACRON PATCH CLOSURE OF THE VSD AND SUTURE CLOSURE OF THE ASD. THE PATIENT WAS DISCHARGED ON DOL 120 WITH A NASAL CANNULA AT .5 LITERS, CONTINUOUS G-TUBE FEEDINGS AND A HOST OF MEDICATIONS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON DOL 137 FOR PNEUMONIA WHICH REQUIRED INTUBATION AND MULTIPLE ANTIBIOTICS. THE PATIENT WAS ABLE TO BE DISCHARGED ON 1 LITER OXYGEN ON DOL 196. THE PATIENT REQUIRED SEVERAL MORE ADMISSIONS TO THE EMERGENCY ROOM/HOSPITAL FOR RESPIRATORY DISTRESS, BUT DID NOT REQUIRE INTUBATION. AT 201 DAYS AFTER THE REPLACEMENT IF THE CONTEGRA VALVE (ON DOL 302), THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTEGRA PULMONARY VALVED CONDUIT MWH MEDTRONIC HEART VALVES, INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention