BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 6509130 · Received April 20, 2017

    Report

    Report Number
    3005619880-2017-00012
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    October 15, 2016
    Report Date
    April 20, 2017
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005010
    PMA / PMN Number
    K051405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT USED CORMATRIX ECM FOR PERICARDIAL CLOSURE PRODUCT FOR AN OFF-LABEL USE IN AN APPLICATION MORE CLOSELY ASSOCIATED WITH THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR. BOTH PRODUCTS ARE IDENTICAL, ONLY THE ASSOCIATED LABELING AND CLEARED INDICATION FOR USE ARE DIFFERENTIATED BETWEEN THE TWO PRODUCTS. THE ASSOCIATED INSTRUCTIONS FOR USE WITH THE PERICARDIAL CLOSURE PRODUCT (ART-20551A) STATES THAT THE PRODUCT IS INTENDED FOR THE RECONSTRUCTION OF THE PERICARDIUM. THE CARDIAC TISSUE REPAIR INSTRUCTIONS FOR USE (ART-20553A) STATES THAT THE PRODUCT IS INTENDED FOR USE AS AN INTRACARDIAC PATCH OR PLEDGET FOR TISSUE REPAIR [I.E., ATRIAL SEPTAL DEFECT (ASD), VENTRICULAR SEPTAL DEFECT (VSD), ETC.] AND SUTURE-LINE BUTTRESSING. NEITHER PRODUCT IS INTENDED FOR A CONDUIT GRAFT COMPLETELY REPLACING PREVIOUS PATIENT TISSUE/VESSEL, AND WOULD REPRESENT AN OFF-LABEL USE FOR EITHER DEVICE. PHYSICIAN STATES THAT HE "WAS PLEASANTLY SURPRISED ABOUT WHAT HE SAW" UPON RE-OPENING PATIENT AND OBSERVING THE INTEGRATION OF THE CORMATRIX ECM AND NOTING IT WAS STILL STRONG, BUT OVERGROWN IN DIAMETER MOST LIKELY ASSOCIATED WITH THE ORIGINAL DIAMETER DETERMINED WHEN FORMING THE ECM MATERIAL TO REPLACE THE AORTIC SECTION DURING ORIGINAL AORTIC REPAIR. A REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH MANUFACTURING LOT M15F1167 SHOWS NO MANUFACTURING/STERILIZATION RELATED NONCONFORMANCES AND THAT ALL QUALITY REQUIREMENTS FOR THE PACKAGED PRODUCT WERE MET PRIOR TO RELEASE TO DISTRIBUTION. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE EXPLANTED TISSUE FROM THE HOSPITAL PATHOLOGY LAB, SHOULD ANY ADDITIONAL DETAILS BE PROVIDED BY THE HOSPITAL A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORMATRIX ECM FOR PERICARDIAL CLOSURE (MODEL CMCV-060-402, LOT #M15F1167) WAS USED ON A (B)(6) MALE PATIENT WEIGHING (B)(6). THE 7CM X 15CM PIECE OF ECM WAS USED IN AN AORTIC ARCH RECONSTRUCTION PROCEDURE IN THE LEFT CHEST ON (B)(6) 2015. THE PATCH HAD BEEN HYDRATED IN A SALINE SOLUTION FOR APPROXIMATELY TWO MINUTES. APPROXIMATELY ONE YEAR LATER, ON (B)(6) 2016, A RESECTION OF THE DILATED CORMATRIX CONDUIT WAS COMPLETED AND REPLACED WITH A GORETEX CONDUIT. THERE WAS NO INITIAL ONSET OF SYMPTOMS OR SERIOUS ADVERSE EVENT/MALFUNCTION THAT DICTATED THE RESECTION AND REPLACEMENT OF THE CORMATRIX ECM. THE PHYSICIAN DETERMINED DURING SUBSEQUENT FOLLOW-UP THAT THE AORTIC REPAIR APPEARED DILATED AND POSITED THAT THE DILATION MAY BE THE EARLY SIGNS OF AN ANEURYSM AND DECIDED TO RE-OPERATE AND REPLACE. UPON RE-OPENING PATIENT, SURGEON DETERMINED THAT THE CORMATRIX PATCH HAD COMPLETELY INTEGRATED AND WAS STILL STRONG, BUT WAS JUST OVERGROWN TO DOUBLE THE DIAMETER OF THE PATIENT'S AORTA. NO STENOSIS WAS OBSERVED. THE EXPLANTED ECM WAS SENT TO HOSPITAL PATHOLOGY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291400 CORMATRIX ECM FOR PERICARDIAL CLOSURE PATCH, PLEDGET AND INTRACARDIAC DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-060-402 M15F1167 00859389005010

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention