BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK PERMACOL PRODUCT

    MDR report key: 3940629 · Received July 8, 2014

    Report

    Report Number
    9617613-2014-00109
    Event Type
    Death
    Date Received
    July 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW: IN AN ARTICLE ENTITLED "THE USE OF PERMACOL MESH IN CONTAMINATED COMPLEX ABDOMINAL WALL DEFECTS" WRITTEN BY BEE MENG LEE ET AL PUBLISHED IN SURGICAL TECHNOLOGY INTERNATIONAL XXIII. THERE WERE FOUR PATIENTS PRESENTED. 1 PT HAD AN UNEVENTFUL COURSE WITH NO COMPLICATIONS. 2 PATIENTS (CASES 2 AND 4) DEVELOPED POSTOPERATIVE FISTULAS. 1 PT DEVELOPED AN INFECTION. THIS IS FOR CASE 2, WHICH WAS A (B)(6) YR OLD MALE WHO HAD A HISTORY OF RADICAL CYSTECTOMY AND ILEAL CONDUIT FORMATION FOR BLADDER CANCER. THIS WAS COMPLICATED WITH A INCISIONAL HERNIA. FIVE DAYS LATER, HE DEVELOPED AN ANASTOMOTIC LEAK. THIS WAS TREATED WITH DRAINAGE, TOTAL PARENTERAL NUTRITION (TPN) AND WOUND MANAGEMENT. WITHIN A FURTHER THREE WEEKS, THE LOWER HALF OF THE SKIN CLOSURE BROKE DOWN AND RETRACTED, LEAVING PERMACOL AND GRANULATION TISSUE IN VIEW. IT WAS FOUND THAT THE LOWER HALF OF THE PERMACOL HAD COMPLETELY DISAPPEARED, LEAVING GRANULATION TISSUE OVER BOWEL IN VIEW AND AN EFFECTIVE ENTERO-ATMOSPHERIC FISTULAS (FIG 3). THIS WAS TREATED WITH DRESSINGS AND, SUBSEQUENTLY, VAC PLACEMENT. AFTER TWO FURTHER MONTHS, ANOTHER SHEET OF PERMACOL WAS APPLIED OVER THE ENTIRE EXPOSED GRANULATION TISSUE ON TOP OF A LAYER OF TISSEEL FIBRIN SEALANT. THIS WAS EFFECTIVE FOR ONE WEEK, UNTIL THE PEG TUBE WAS PULLED OUT OF THE FISTULA UNDER TENSION AND THE PERMACOL SHEET BECAME DISLODGED. TWO FURTHER LAPAROTOMIES WITH BOWEL RESECTION AND ANASTOMOSIS WERE ATTEMPTED, BUT RECURRENT FISTULA FORMATION WAS UNAVOIDABLE. ONGOING SEPSIS FROM MULTIPLE SOURCES AND MALNUTRITION EVENTUALLY LED TO DETERIORATION AND DEATH AFTER A TOTAL PERIOD OF 156 DAYS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT PRESENTED TO THE INSTITUTION HAVING DEVELOPED AN EROSION OF THE SMALL BOWEL INTO THE MESH WITH LOCALIZED PERITONITIS. DURING SURGERY, EXTENSICE ADHESIOLYSIS WAS PERFORMED WITH PARTIAL REMOVAL OF THE SYNTHETIC MESH. A SMALL BOWEL RESECTION AND PRIMARY ANASTOMOSIS WERE PERFORMED. DUE TO THE LACK OF ABDOMINAL WALL MUSCULATURE, THE ABDOMEN WAS TEMPORARILY CLOSED WITH A NEGATIVE PRESSURE (VAC) DRESSING. ONE WEEK LATER, A REPEAT INCISIONAL HERNIA REPAIR WAS PERFORMED FROM XIPHISTERNUM TO PUBIS WITH THE DEVICE, WHICH ENCOMPASSED AND SURROUNDED THE ILEAL CONDUIT. FIVE DAYS FOLLOWING THAT PROCEDURE, THE PATIENT DEVELOPED AN ANASTOMOTIC LEAK THAT WAS TREATED WITH DRAINAGE, TOTAL PARENTERAL NUTRITION AND WOUND MANAGEMENT. THREE WEEKS FOLLOWING THAT EVENT, THE LOWER HALF OF THE SKIN CLOSURE BROKE DOWN AND RETRACTED, LEAVING THE DEVICE AND GRANULATION TISSUE IN VIEW. IT WAS DISCOVERED THAT THE LOWER HALF OF THE DEVICE HAD COMPLETELY DISAPPEARED, LEAVING GRANULATION TISSUE OVER THE BOWEL IN VIEW AND AN EFFECTIVE "ENTERO-ATMOSPHERIC FISTULA." THIS WAS TREATED WITH DRESSINGS AND, SUBSEQUENTLY, VAC PLACEMENT. MANAGEMENT OF THE VAC BECAME PROBLEMATIC DUE TO THE HIGH VOLUME OF BOWEL EFFLUENT CAUSING BLOCKAGES AND INTUBATIONS OF THE FISTULA WERE COMPLICATED BY RECURRENT DISPLACEMENT OF THE TUBES. AFTER TWO FURTHER MONTHS, ANOTHER DEVICE WAS APPLIED OVER THE ENTIRE EXPOSED GRANULATION TISSUE ON TOP OF A LAYER OF TISSEEL FIBRIN SEALANT. THE PURPOSE WAS TO ALLOW A STOMA BAG TO BE APPLIED DIRECTLY TO THE DEVICE AROUND THE FISTULA AND NEGATE THE NEED FOR FURTHER DRESSINGS. THIS WAS EFFECTIVE FOR ONE WEEK, UNTIL THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PULLED OUT OF THE FISTULA UNDER TENSION AND THE DEVICE BECAME DISLODGED. TWO MORE LAPAROTOMIES WITH BOWEL RESECTION AND ANASTOMOSIS WERE ATTEMPTED, BUT RECURRENT FISTULA FORMATION WAS UNAVOIDABLE. ONGOING SEPSIS FROM MULTIPLE SOURCES AND MALNUTRITION EVENTUALLY LED TO THE DETERIORATION AND DEATH AFTER A TOTAL PERIOD OF 156 DAYS. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES BUT NOTHING FURTHER WAS PROVIDED. SHOULD THIS INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397838 UNK PERMACOL PRODUCT NONE FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death