BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    MDR report key: 9233812 · Received October 24, 2019

    Report

    Report Number
    1835959-2019-00005
    Event Type
    Injury
    Date Received
    October 24, 2019
    Report Date
    October 23, 2019
    Manufacturer
    COOK BIOTECH
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT IDENTIFIER NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME MOST LIKELY EITHER AXOGUARD NERVE CONNECTOR OR AXOGUARD NERVE PROTECTOR. PRODUCT COMMON NAME MOST LIKELY NERVE CONNECTOR OR NERVE PROTECTOR. PRODUCT CODE MOST LIKELY JXI. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT RPN UNKNOWN, PRODUCT UNSPECIFIED. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. EXPLANT DATE NOT PROVIDED BY THE COMPLAINANT. OCCUPATION: SENIOR REGULATORY AFFAIRS MANAGER. 510(K) MOST LIKELY K162741 OR K132660. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE PUBLICATION, A REVIEW OF THE AXOGUARD NERVE PROTECTOR IFU FP0067-03B, AND 3) A REVIEW OF THE AXOGUARD NERVE CONNECTOR IFU FP0068-01G. A REVIEW OF THE IFUS INDICATED THAT ¿INFECTION, ALLERGIC REACTION, AND ACUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION)¿ ARE POTENTIAL COMPLICATIONS. THE IFU ALSO NOTES THAT IF THESE ¿CONDITIONS OCCUR AND CANNOT BE RESOLVED, CAREFUL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED." THE ROOT CAUSE, OF THE PATIENT¿S POST-OP TENOSYNOVITIS, IS INCONCLUSIVE. IT IS UNKNOWN WHAT ADDITIONAL MEDICATIONS, FLUIDS DURING SURGERY, POST-OP DRESSINGS, OR WOUND CARE WAS UTILIZED ON THE PATIENT. SUCH ITEMS COULD ALSO CONTRIBUTE TO THE PATIENT¿S SIGNS / SYMPTOMS AND PATHOLOGY RESULTS. THE PATIENT'S PRE-OP NUMBNESS (PRIOR TO AXOGUARD) WAS RESOLVED POST AXOGUARD PLACEMENT. SWELLING IS A KNOWN POTENTIAL COMPLICATION OF THE SURGICAL PROCEDURE. THE PATIENT UNDERWENT 2 HAND SURGERIES WITHIN 5 MONTHS, IN ADDITION TO THE DAMAGE THAT MAY HAVE BEEN CAUSED BY THE UNDERLYING CONDITION; THEREFORE, ACUTE AND CHRONIC INFLAMMATION COULD BE EXPECTED.

    Description of Event or Problem · 1

    PUBLICATION / INFLAMMATORY REACTIONS TO XENOGENIC NERVE WRAPS. ABSTRACT: CASE: RECURRENT CARPAL TUNNEL SYNDROME IS A CHALLENGING PROBLEM. NERVE WRAPS HAVE BEEN INTRODUCED AS A BARRIER TO PREVENT SCAR TRACTION NEURITIS FOR USE DURING REVISION CARPAL TUNNEL SURGERY. WE PRESENT 3 CASES OF INFLAMMATORY RESPONSES TO BOVINE COLLAGEN AND PORCINE SUBINTESTINAL MUCOSAL NERVE WRAPS IN PATIENTS UNDERGOING REVISION CARPAL TUNNEL SURGERY. NO PATIENT HAD EVIDENCE OF INFECTION, AND PATHOLOGY REVEALED ACUTE AND CHRONIC INFLAMMATION. ALL 3 PATIENTS RESPONDED FAVORABLY FOLLOWING WRAP REMOVAL. CONCLUSIONS: WE RECOMMEND CAUTION WITH THE ROUTINE USE OF NERVE WRAPS IN THE SETTING OF REVISION CARPAL TUNNEL SURGERY. ONLY 1 OF THE 3 CASES INVOLVED THE USE OF AN AXOGEN PRODUCT. CASE 2. A 47-YEAR-OLD WOMAN PRESENTED WITH NUMBNESS AND TINGLING IN THE MEDIAN NERVE DISTRIBUTION. SHE UNDERWENT OPEN CARPAL TUNNEL RELEASE, BUT HAD PERSISTENT SYMPTOMS WITH NO IMPROVEMENT POSTOPERATIVELY. ELECTRODIAGNOSTIC STUDIES WERE UNCHANGED FROM THE PREOPERATIVE STUDY. EXAMINATION DEMONSTRATED MILD THENAR ATROPHY AND 2-POINT DISCRIMINATION IN THE MEDIAN NERVE DISTRIBUTION WAS 12 TO 15 MM. FIVE MONTHS POSTOPERATIVELY, SHE UNDERWENT MEDIAN NERVE EXPLORATION. INTRAOPERATIVELY, THERE WAS TENOSYNOVITIS SURROUNDING HER FLEXOR TENDONS, BUT NO EVIDENCE OF INFECTION. SURGICAL PATHOLOGY SHOWED BENIGN, MILDLY HYPERPLASTIC NONINFLAMMATORY SYNOVIUM A LIMITED INTERNAL NEUROLYSIS WAS PERFORMED UNDER LOUPE MAGNIFICATION, AND THE MEDIAN NERVE WAS WRAPPED WITH A PORCINE SUBINTESTINAL MUCOSAL NERVE WRAP (AXOGUARD; AXOGEN). TWO MONTHS FOLLOWING REVISION, SHE RETURNED WITH PALPABLE TENOSYNOVITIS AT THE WRIST PROXIMAL TO THE CARPAL CANAL (FIG. 5). HER NUMBNESS HAD RESOLVED. SHE UNDERWENT EXPLANTATION OF THE NERVE WRAP. INTRAOPERATIVELY, THERE WAS EXTENSIVE HYPERTROPHIC TENOSYNOVIUM SURROUNDING THE NERVE WRAP AND THE FLEXOR TENDONS, EXTENDING DISTALLY TO THE SUPERFICIAL ARCH. ROUTINE, ACID FAST, ATYPICAL MYCOBACTERIUM AND FUNGAL CULTURES WERE ALL NEGATIVE. PATHOLOGY REVEALED FIBROVASCULAR TISSUE WITH FIBRINOID NECROSIS, AREAS OF ACUTE INFLAMMATION, FOCAL AREAS OF PALISADING GRANULOMATOUS REACTION (FIG. 5), AS WELL AS AREAS OF CHRONIC INFLAMMATION. FIVE MONTHS AFTER NERVE WRAP EXPLANTATION, SHE WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029037 AXOGUARD NERVE CONNECTOR AND PROTECTOR JXI COOK BIOTECH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention