BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM

    MDR report key: 5574325 · Received April 13, 2016

    Report

    Report Number
    3005619880-2016-00007
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    February 23, 2016
    Report Date
    April 13, 2016
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVALUATION. PRODUCT AND LOT INFORMATION IS UNAVAILABLE. BOTH THE IMPLANTING SURGEON AND THE STAFF AT THE HOSPITAL WHERE THE VALVE WAS EXPLANTED INDICATED THAT THE RECURRENT ENDOCARDITIS WAS DIRECTLY RELATED TO INTRAVENOUS DRUG ABUSE AND PATIENT LIFESTYLE. INFECTION OF THE PATCH OR SURROUNDING TISSUE CAN AFFECT PATCH OR SUTURE LINE INTEGRITY. THEREFORE THE RECURRENT ENDOCARDITIS LIKELY CONTRIBUTED TO WEAKENING OF SURROUNDING TISSUE AND EMBOLIZATION OF THE FABRICATED ECM VALVE. THE CAUSE OF THIS EVENT IS ASSOCIATED WITH THE PATIENT'S ONGOING INTRAVENOUS DRUG ABUSE. THE USE OF THE CORMATRIX ECM TO CONSTRUCT HEART VALVES IS NOT AN FDA CLEARED INDICATION. THIS IS AN OFF-LABEL USE OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PRODUCT, WHICH IS INDICATED FOR INTRACARDIAC PATCH OR PLEDGET FOR TISSUE REPAIR AND SUTURE-LINE BUTTRESSING, AND THE CORMATRIX ECM FOR PERICARDIAL CLOSURE PRODUCT, WHICH IS INDICATED FOR THE RECONSTRUCTION AND REPAIR OF THE PERICARDIUM.

    Description of Event or Problem · 1

    ON (B)(6) 2016, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING CORMATRIX ECM. DETAILS ARE PROVIDED BELOW: IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD BEEN ADMITTED TO THE INITIAL REPORTING HOSPITAL FOR TREATMENT OF RECURRENT ENDOCARDITIS. THE PATIENT HAD A HISTORY OF HEROIN INTRAVENOUS DRUG ABUSE AND ENDOCARDITIS. THE PATIENT HAD BEEN PREVIOUSLY TREATED FOR ENDOCARDITIS AND HAD A TRICUSPID VALVE REPLACEMENT PERFORMED ON (B)(6) 2015 IN A HOSPITAL LOCATED IN A DIFFERENT STATE. THE PATIENT WAS INITIALLY REPORTED AS STABLE AND ECHOCARDIOGRAMS INDICATED ONLY MODERATE REGURGITATION. LATER, ON (B)(6) 2016, THE PATIENT REQUIRED EMERGENCY HEART SURGERY DUE TO A RAPID CHANGE IN STATUS. WHEN THE RIGHT ATRIUM WAS OPENED, THE TRICUSPID VALVE WAS NOT PRESENT BUT HAD EMBOLIZED TO THE PULMONARY ARTERY. THE DETACHMENT LIKELY OCCURRED JUST PRIOR TO SURGERY. THE EXPLANTING SURGEON BELIEVED THAT THE TRICUSPID VALVE WAS LIKELY FABRICATED FROM CORMATRIX ECM. THE SURGEON IMPLANTED A BIO-PROSTHETIC VALVE IN THE TRICUSPID LOCATION. HOSPITAL PATHOLOGY IDENTIFIED ACTIVE INFECTION IN EXPLANTED TISSUE INCLUDING FUNGAL, GRAM POSITIVE RODS, AND MYCOBACTERIUM ABCESSUS. THE PATIENT WAS REPORTED AS DOING WELL AND HAD BEEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. CORMATRIX WAS LATER ABLE TO CONTACT THE IMPLANTING SURGEON IN THE OTHER STATE. THE IMPLANTING SURGEON INDICATED THAT THE PATIENT DID NOT HAVE A PERIVALVULAR ABSCESS AND OVERALL THE NATIVE TISSUE THAT THE ECM VALVE WAS SUTURED TO APPEARED HEALTHY AT THE TIME OF IMPLANT. THE VALVE WAS SUTURED INTO PLACE USING PROLENE 4.0 SUTURES. THE IMPLANTING SURGEON INDICATED THAT THERE WAS EVIDENCE THAT THE PATIENT WAS SHOOTING UP (INTRAVENOUS DRUG ABUSE) PRE AND POST-OP WHILE IN THE HOSPITAL. THE PATIENT DID NOT STAY IN THE HOSPITAL SYSTEM TO COMPLETE A DRUG ADDICTION TREATMENT PROGRAM. BOTH THE IMPLANTING SURGEON AND THE STAFF AT THE HOSPITAL WHERE THE VALVE WAS EXPLANTED INDICATED THAT THE RECURRENT ENDOCARDITIS WAS DIRECTLY RELATED TO INTRAVENOUS DRUG ABUSE AND PATIENT LIFESTYLE. ALTHOUGH PRODUCT AND LOT INFORMATION IS CURRENTLY UNKNOWN, IT IS LIKELY THAT THE VALVE WAS FABRICATED FROM EITHER THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR OR FROM THE CORMATRIX ECM FOR PERICARDIAL CLOSURE. THE USE OF THE CORMATRIX ECM TO CONSTRUCT HEART VALVES IS NOT AN FDA CLEARED INDICATION. THIS IS AN OFF-LABEL USE OF THE CORMATRIX ECM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229350 CORMATRIX ECM PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R