BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELHIGH

    MDR report key: 967847 · Received December 18, 2007

    Report

    Report Number
    MW5004724
    Event Type
    Injury
    Date Received
    December 18, 2007
    Date of Event
    February 23, 2005
    Report Date
    December 7, 2007
    Manufacturer
    SHELHIGH, INC.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING HER CICU STAY, THE PATIENT HAD BEEN STARTED ON ENTERAL FEEDS, HOWEVER, ON POSTOPERATIVE DAY #18 AFTER THE NORWOOD OPERATION, THERE WAS CONCERN FOR NECROTIZING ENTEROCOLITIS (NEC) DUE TO BLOOD FOUND IN THE STOOL. SHE WAS MADE N.P.O. AND STARTED ON TOTAL PARENTERAL NUTRITION. TRIPLE ANTIBIOTIC COVERAGE WAS INITIATED FOR SEVEN DAYS. FEEDINGS WERE THEN GRADUALLY REINTRODUCED. AT THE SAME TIME, A RISE IN WHITE BLOOD CELLS PROMPTED A SEPTIC WORKUP. THE URINE WAS POSITIVE FOR E. COLI AND BLOOD FOR STREPTOCOCCUS VIRIDANS. THE PATIENT WAS TRANSFERRED TO THE SURGICAL FLOOR ON POSTOPERATIVE DAY #19 FROM THE NORWOOD, WHERE SHE REMAINED FOR ANOTHER TWO WEEKS. SHE RECEIVED HER FULL COURSE OF ANTIBIOTICS AND WAS TITRATED OFF OF TOTAL PARENTAL NUTRITION AND TRANSITIONED TO ENTERAL FEEDS. SHE UNDERWENT A BIDIRECTIONAL GLENN OPERATION IN 2005. ON POSTOPERATIVE DAY #20 STATUS POST BIDIRECTIONAL GLENN PROCEDURE AND BILATERAL PULMONARY ARTERY RECONSTRUCTION WITH REMOVAL OF PULMONARY ARTERY STENTS, SHE HAD A CHEST TUBE PLACED IN HER LEFT PLEURAL SPACE THAT REVEALED A SIGNIFICANT CHYLOUS EFFUSION WHICH CONTINUES TO DRAIN OVERNIGHT. SHE HAD A PICC LINE PLACED IN HER LEFT UPPER EXTREMITY AND HAD AN INCISION AND DRAINAGE OF HER STERNAL WOUND. PUS WAS NOTED FROM THE WOUND AND WAS SENT FOR CULTURE AND GREW ENTEROBACTER CLOACAE. SHE WAS TREATED MEDICALLY WITH ZOSYN AND A WOUND-VAC WAS PLACED, AND THE INFECTION EVENTUALLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELHIGH BOVINE PERICARDIUM DXZ SHELHIGH, INC. SHP-555-11AP 050113-NR

    Patients

    Seq Age Sex Outcome Treatment
    1 220 DA Hospitalization| L| R 2 3MM X 8MM STENTS| 3.5 MM GORE-TEX SHUNT| 6 MM RING GORE-TEX TUBE| GORE-TEX MEMBRANE