BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 2932252 · Received January 25, 2013

    Report

    Report Number
    3005619880-2013-00004
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K11187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSES WERE "HERALD BLEED STATUS POST LEFT CAROTID ENDARTERECTOMY". EXPLORATION OF THE LEFT NECK WAS PERFORMED AND A "PSEUDOANEURYSM TYPE CAVITY WAS ENCOUNTERED, CLOT EXTENDING ON TOP OF THE VESSEL, AND AT THE ARTERIOTOMY ON THE COMMON CAROTID, THERE WAS A 1 TO 1.5 CM HOLE WITH ABSENCE OF PATCH". ALTHOUGH THERE WAS NO EVIDENCE OF THE MATRIX IN THIS AREA, THE SUTURE LINE WAS OBSERVED TO BE TOTALLY INTACT. THE REMAINING PATCH WAS REMOVED AND PATCH ANGIOPLASTY OF THE LEFT CAROTID ENDARTERECTOMY SITE USING BOVINE PERICARDIUM WAS PERFORMED. IN FOLLOW-UP CORRESPONDENCE ON (B)(4) 2013, THE OPERATING PHYSICIAN INDICATED THE PROBLEM WAS PROBABLY CAUSED BY HEMATOMA ORIGINATING FROM TEAR IN THE PT'S NATIVE ARTERY. AS OF (B)(6) 2013, THE PT IS DOING FINE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AN EVENT WAS REPORTED TO CORMATRIX CARDIOVASCULAR INVOLVING THE CORMATRIX ECM FOR CAROTID REPAIR. ON (B)(6), 2012, SUBJECT (B)(6), A PT PART OF THE (B)(4) STUDY, WAS IMPLANTED WITH THE CORMATRIX ECM FOR CAROTID REPAIR PRODUCT. ON (B)(6) 2012, THE PT HAD A 30-DAY DOPPLER ULTRASOUND PERFORMED ON THE PROCEDURAL SITE AND IT WAS REPORTED TO BE "CLEAR". ON (B)(6) 2012, THE SUBJECT PRESENTED TO THE EMERGENCY ROOM WITH A WEEK HISTORY OF LEFT NECK SWELLING WITH A LARGE BRUISE. THE SWELLING WAS UNDERNEATH THE CAROTID INCISION, APPROX 3 CM TO 4 CM LONG BY 2 CM WIDE, ERYTHEMATOUS BEYOND THOSE BOUNDARIES WITH A WHITE PUSTULE DOWN AT THE BASE OF THE INCISION. HEAD AND NECK CTA WERE PERFORMED AND SUGGESTED POSSIBLE EVOLVING HEMATOMA, BUT THERE WAS "NO EVIDENCE THAT THE LESION REPRESENTS A PSEUDOANEURYSM". ON (B)(6) 2012, IN LATE MORNING, THE PT WAS OBSERVED TO BE BLEEDING OUT OF THE BOTTOM OF THE BRUISE, NEAR THE PUSTULE. THE PT WAS ADMITTED TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36080 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC PEPT DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006-609 M12E1053

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention