BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PLASTIC SURGERY MATRIX XS

    MDR report key: 2844589 · Received November 16, 2012

    Report

    Report Number
    3005920706-2012-00007
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO SURGEON AND REVIEWED RELEVANT MEDICAL RECORDS. BASED ON ITS REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OF PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ON (B)(6) 2012, PT UNDERWENT SURGICAL INTERVENTION DUE TO METASTATIC RENAL CELL CARCINOMA NON-RESPONSIVE TO RADIATION THERAPY AND CHEMOTHERAPY WITH PROGRESSIVE TO THE LUNGS AND AN OPEN, DRAINING WOUND FROM THE INFECTED TUMOR BED IN THE ARM. PERFORMED MOBILIZATION OF SUBCLAVIAN VEIN AND ARTERY, A FOREQUARTER AMPUTATION ON THE LEFT SIDE WITH LATISSIMUS TO PECTORALIS MUSCLE FLAPS FOR CLOSURE; ADJACENT SOFT TISSUE TRANSFERS OF GREATER THAN 200 SQ CM; PLACEMENT OF STIMULAN PELLETS, 20 ML LOADED WITH 240 MG OF TOBRAMYCIN, 50 MG OF VANCOMYCIN PER MIXTURE; AND PLACEMENT OF ACELL MATRISTEM PSMX 150 SQ CM FOR TISSUE HEALING. PATHOLOGICAL ANALYSIS ON (B)(6) 2012 SHOWS METASTATIC RENAL CELL CARCINOMA. ON (B)(6) 2012, PT PRESENTS IN CLINIC WITH AN AREA OF SKIN NECROSIS OVER THE MORE PROXIMAL PORTION OF THE FLAP WITH COPIOUS DRAINAGE OF FLUIDS. POTENTIAL PROBLEMS OF FURTHER SURGICAL INTERVENTION TO RADIATION INDUCED WOUNDS ARE DISCUSSED WITH PT, INCLUDING INFECTION AND WOUND HEALING PROBLEMS, AND NEED FOR FURTHER SURGERY. (NO REPORT YET MADE TO ACELL.) ON (B)(6) 2012, SURGICAL DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, DEEP TENDON, MUSCLE BELLY, PERIOSTEUM AND BONE. REMOVAL OF ACELL PRODUCT TO SUBCLAVIAN VESSELS, ADJACENT SOFT TISSUE TRANSFERS OF ABOUT 60 SQ CM AND PLACEMENT OF STIMULAN PELLETS WITH 240 MG TOBRAMYCIN AND 500 MG VANCOMYCIN PER 10 ML MIXTURE. PATHOLOGY PERFORMED ON (B)(6) 2012 REVEALS FIBROADIPOSE TISSUE WITH EXTENSIVE NECROSIS, DYSTROPHIC CALCIFICATIONS, AND HEAVY ACUTE INFLAMMATION. MEDICAL RECORDS DO NOT INCLUDE INFO REGARDING BACTERIAL OR FUNGAL COLONIZATION. INITIAL REPORT PROVIDED TO SALES REP OF MFR. DEVICE WAS USED IN AN OFF LABEL ONCOLOGIC SURGICAL PROCEDURE. THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR THIS INDICATION HAVE NOT BEEN DEMONSTRATED AND THERE IS NO FDA CLEARANCE/APPROVAL FOR THIS APPLICATION. ACELL IS IN THE PROCESS OF CONDUCTING A COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    ACELL PRODUCT WAS IMPLANTED INTO PT ON (B)(6) 2012. THIS PRODUCT WAS LATER EXPLANTED DURING A PROCEDURE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM PLASTIC SURGERY MATRIX XS FTM, SURGICAL MESH FTM ACELL INC. SM1193-60

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 240MG TOBRAMYCIN| STIMULAN PELLETS| 500MG VANCOMYCIN PER 10ML MIXTURE