BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 2762727 · Received September 21, 2012

    Report

    Report Number
    1835959-2012-00011
    Event Type
    Death
    Date Received
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    COOK BIOTECH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/501 K UNK AT THIS TIME AS SPECIFIC DEVICE USED IS UNK. EC METHOD CODE DESC -1- DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS IN PROCESS AT GATHERING ADDITIONAL DETAILS SURROUNDING EACH REPORTED OUTCOME AND TO IDENTIFY SPECIFIC PRODUCT USED. INVESTIGATION INTO THIS REPORT IS ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 8-12 WEEKS WITH FURTHER DETAILS AS TO THE FINDINGS OF THIS INVESTIGATION, BASED ON INFORMATION AVAILABLE, INCLUDING SPECIFIC DEVICE(S) USED.

    Description of Event or Problem · 1

    BACKGROUND: PROSTHETIC PATCHES ARE WIDELY USED FOR CONGENITAL DIAPHRAGMATIC HERNIA(CDH) REPAIR. WE COMPARED THE COMPLICATION RATE OF ABSORBABLE (SURGISIS [SIS]; COOK BIOTECH, INC, (B)(4)) AND NONABSORBABLE (POLYTETRAFLUOROETHYLENE [PTFE]) MATERIALS FOR THIS PURPOSE. METHODS: THIS IS A RETROSPECTIVE REVIEW OF ALL NEONATES WITH CDH UNDERGOING PATCH CLOSURE AT OUR INSTITUTION OVER 10 YEARS. META-ANALYSIS WAS ALSO PERFORMED COMBINING OUR DATA WITH THE PUBLISHED LITERATURE EXAMINING THE EFFECT OF PATCH TYPE ON RECURRENCE AND SMALL BOWEL OBSTRUCTION (SBO). (B)(4) 2012 - AT THIS TIME, WE DO NOT KNOW ANY FURTHER INFORMATION THAN THE FOLLOWING THAT WAS AVAILABLE IN THE PAPER: RECURRENCE RATE (SIS, 4 [31%]; PTFE, 3[33%]; P, NONSIGNIFICANT [NS]), INCIDENCE OF POSTOPERATIVE SBO (SIS, 1 [7%] VS PTFE, 2[22%]; P, NS), AND MORTALITY (SIS, 2[15%] AND PTFE, 2[22%]; P, NS). RESULTS: PRIMARY PATCH (13 SIS, 9 PTFE) REPAIR WAS PERFORMED IN 22 (26%) OF 84 PTS WITH CDH. GROUPS WERE COMPARABLE IN TERMS OF DEMOGRAPHICS, HOSPITAL STAY, VENTILATOR DAYS, NEED FOR HIGH FREQUENCY OSCILLATION, AGE AT SURGERY, AND LENGTH OF FOLLOW-UP. LIKEWISE, RECURRENCE RATE (SIS, 4 [31%]; PTFE, 3[33%]; P, NONSIGNIFICANT [NS]), INCIDENCE OF POSTOPERATIVE SBO (SIS, 1[7%] VS PTFE, 2[22%]; P, NS), AND MORTALITY (SIS, 2[15%] AND PTFE, 2[22%]; P, NS) WERE SIMILAR. META-ANALYSIS FAILED TO FIND A SIGNIFICANT DIFFERENCE BETWEEN SIS AND PTFE BOTH FOR RECURRENCE RATE (ODDS RATIO, 1.21 [0.51-2.84]; P, NS) AND SBO (ODDS RATIO, 1.47 [0.44-4.96]; P, NS). CONCLUSIONS: THERE WAS NO DIFFERENCE IN THE INCIDENCE OF CDH RECURRENCE, SBO, OR MORTALITY POST-CDH PATCH REPAIR USING EITHER SIS OR PTFE IN OUR SERIES. META-ANALYSIS FAILED TO SHOW ANY DIFFERENCE IN RECURRENCE ANS SBO RATES BETWEEN THE 2 MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NONE FTL COOK BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R