BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    MDR report key: 3538641 · Received December 18, 2013

    Report

    Report Number
    1835959-2013-02776
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    August 27, 2013
    Report Date
    December 17, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION - 1 BR J SURG. 2013 DEC; 100(13); 1833-7 DOI: 10.1002/BJS 9306. NOT PROVIDED IN THE ARTICLE. SPECIFIC AGE NOT PROVIDED IN THE ARTICLE; NEWBORNS; (B)(6). NOT PROVIDED IN THE ARTICLE. SPECIFIC WEIGHT NOT PROVIDED IN THE ARTICLE, BIRTH WEIGHT RANGED FROM (B)(6) GRAMS. NOT PROVIDED BY REPORTER; ARTICLE DATE IS LISTED AS DATE OF EVENT. LOT NUMBER NOT PROVIDED IN ARTICLE. EXPIRATION DATE UNKNOWN DUE TO NO LOT NUMBER PROVIDED. SPECIFIC DATE NOT PROVIDED IN THE ARTICLE; HOWEVER, IMPLANTS BELIEVED TO BE IN THE 2004-2005 TIME PERIOD. NOT PROVIDED IN THE ARTICLE. MANUFACTURE DATE UNKNOWN DUE TO NO LOT NUMBER PROVIDED. METHOD - 1 - ACTUAL DEVICE NOT EVALUATED C91897, FDA 3263 AS DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS - 1 NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED C92084; FDA 3221 AS DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSIONS: ROOT CAUSE ANALYSIS. THIS MDR IS RELATED TO MDR 1835959-2013-02777. INVESTIGATION EVALUATION: INVESTIGATION INTO THIS FEEDBACK INCLUDED: A REVIEW OF THE FEEDBACK DETAILS, COMMUNICATION WITH THE ASSOCIATED COOK SALES REPRESENTATIVE, COMMUNICATION WITH THE ARTICLE'S APPOINTED CORRESPONDENCE PERSON, AND REVIEW OF THE FEEDBACK BY THE INCIDENT INVESTIGATION COMMITTEE. SUMMARY OF INVESTIGATION FINDINGS: DUE TO THE NATURE OF CONGENITAL DIAPHRAGMATIC HERNIAS AND THE FRALITY OF A NEWBORN, THE EVENT (HERNIA RECURRENCE WHICH REQUIRED PROMPT INTERVENTION), WAS DETERMINED TO BE LIFE THREATENING AND THUS AN MDR IS BEING FILED. THE ROOT CAUSE OF THE CONGENITAL DIAPHRAGMATIC HERNIA RECURRENCE AND THE DEGRADATION OF THE GRAFT IS LIKELY RELATED TO THE USER TECHNIQUE FOR PLACEMENT OF THE BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT AND THE UNDERLYING CONDITION BEING TREATED. SURGICAL EXPERIENCE INDICATES THAT SUTURING OR STAPLING GRAFT SHEETS WITH CLOSE TISSUE APPROXIMATION PRODUCES BETTER OUTCOMES. HOWEVER, DUE TO THE NATURE OF THE CONGENITAL DIAPHRAGMATIC HERNIA BEING TREATED, THIS IS NOT ENTIRELY POSSIBLE AND THE GRAFT IS BELIEVED TO HAVE BEEN PLACED IN A BRIDGING MANNER. GRAFT DEGRADATION CAN HAPPEN IF THE GRAFT IS NOT IN CONTACT WITH HEALTHY WELL-VASCULARIZED TISSUE TO PROMOTE GRAFT INCORPORATION (SUCH IS LIKELY THE CASE WHEN THE GRAFT IS PLACED IN A BRIDGING MANNER.) ADDITIONALLY, HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF ANY HERNIA REPAIR PROCEDURE.

    Description of Event or Problem · 1

    A PAPER PUBLISHED IN THE BRITISH JOURNAL OF SURGERY EVALUATED CONTEMPORARY OUTCOMES FOLLOWING PATCH REPAIR OF CONGENITAL DIAPHRAGMATIC HERNIAS AT A PEDIATRIC SURGICAL CENTER. THIS STUDY WAS CONDUCTED ON NEWBORNS BETWEEN THE DATES 02/01/1990 AND 11/01/2010. THE PAPER REVEALED THAT A NEWBORN WAS IMPLANTED WITH A SURGISIS GRAFT FOR THE REPAIR OF A CONGENITAL DIAPHRAGMATIC HERNIA AND THAT THE NEWBORN HAD A RECURRENCE OF THE ORIGINAL DEFECT. COMMUNICATION WITH AN AUTHOR OF THE ARTICLE REVEALED THAT THE NEWBORN HAD A LARGE LEFT SIDED CONGENITAL DIAPHRAGMATIC DEFECT. SURGISIS WAS USED TO REPAIR THE DEFECT. WITHIN A FEW WEEKS OF THE PRIMARY REPAIR, THE BABY BEGAN EXPERIENCING RESPIRATORY INSTABILITY AND FEEDING PROBLEMS FOR WHICH HE/SHE WAS SENT TO RADIOLOGY. THIS REVEALED A RECURRENT LEFT SIDED HERNIA. UPON REOPERATION, THE SURGISIS GRAFT WAS REPORTEDLY FOUND TO HAVE DEGRADED. AFTER THE REVISIONAL SURGERY THE NEWBORN IMPROVED WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661544 BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L NONE REPORTED IN THE ARTICLE