BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD PERICARDIUM WITH APEX PROCESSING

    MDR report key: 2916831 · Received January 15, 2013

    Report

    Report Number
    2032282-2013-00009
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 10, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    PMA / PMN Number
    K982282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED CONCERNING DETAILS REGARDING THE CASE. FOLLOW-UP MEDICAL ASSESSMENT SUMMARY: DUE TO THE KNOWN CHARACTERISTIC OF ANY IMPLANTABLE COLLAGEN TO POTENTIALLY AUGMENT THE INFECTIOUS RESPONSE TO CONTAMINATION, WE CANNOT RULE OUT THAT THE PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED INFECTIOUS COMPLICATION. THE MANUFACTURING FACILITY, BAXTER SYNOVIS, COMPLETED THE INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED THROUGH REVIEW OF APPLICABLE MANUFACTURING RECORDS. THIS IS A KNOWN COMPLICATION OF THIS SURGERY WITH OTHER POTENTIAL CAUSES, AS OUTLINED IN THE INITIAL MEDICAL ASSESSMENT. THE BATCH RECORD WAS REVIEWED AND FOUND NO DEVIATION THAT MAY HAVE CONTRIBUTED TO THE INFECTIONS. A REVIEW OF THE COMPLAINT DATABASE FOUND NO OTHER SIMILAR ADVERSE EVENTS REPORTED FOR THE GIVEN LOT. NO FURTHER INVESTIGATION IS POSSIBLE AS THE UNUSED PRODUCT WAS SENT TO THE FDA FOR TESTING (BY THE USER FACILITY). BASED ON ALL INVESTIGATION ACTIVITIES THE CAUSE OF THIS INFECTION CANNOT BE ATTRIBUTED TO THE DURA-GUARD PATCH. BAXTER HAS MADE A FREEDOM OF INFORMATION ACT REQUEST AS OF 29-JAN-2013 FOR THE RESULTS. CONFIRMATION WAS RECEIVED THAT THE FDA HAS RECEIVED THE REQUEST. ONCE THE INFORMATION IS RECEIVED THE COMPLAINT WILL BE REOPENED TO ADD THE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS ONE OF THREE CASES FROM ONE DEPARTMENT THAT EXPERIENCED POSTOPERATIVE BRAIN ABSCESS FORMATION. ALL THREE PATIENTS HAVE BEEN IMPLANTED WITH DURA-GUARD FOR DURAL RECONSTRUCTION AND ALL THREE EXPERIENCED THE SAME COMPLICATION. IN TWO CASES PROPIONIBACTERIUM ACNES HAS BEEN ISOLATED BACTERIOLOGICALLY, WHILE THE THIRD PATIENT EXPERIENCED A STAPHYLOCOCCUS AUREUS INFECTION. APART OF THESE CASES DURA-GUARD HAS BEEN USED IN OTHER FOUR PATIENTS WITHOUT INFECTIVE COMPLICATIONS. IN THE INVESTIGATION OF THE INFECTION PREVENTION PROGRAM AT (B)(6) MEDICAL CENTER IT HAS BEEN NOTED THAT THE FIRST 2 CASES GREW THE SAME P. ACNES, AND WERE DONE BY THE SAME SURGEON, IN THE SAME OPERATING ROOM, AND SHARED TWO OTHER OR PERSONNEL IN COMMON. THE FIRST CASE WAS EXTENSIVE, LASTING 8 HOURS, WHILE THE SECOND CASE WAS SHORT, AND FINISHED IN 2 HOURS. THE THIRD CASE WAS SIMILAR IN THAT THE PATIENT RETURNED AFTER DISCHARGE COMPLAINING OF PHOTOPHOBIA, UNDERWENT MRI, REOPERATION AND WAS FOUND TO HAVE A PUS COLLECTION DIRECTLY UNDER THE DURA GUARD PATCH. THIS PATIENT HOWEVER GREW (B)(6), WAS OPERATED ON BY A DIFFERENT SURGEON, IN A DIFFERENT O.R. THEATRE, USING DIFFERENT PERSONNEL, AND THAT PATIENT WAS AN EMERGENT CLOSED TRAUMA CASE, NOT A SLATED PROCEDURE. THE PRESENCE OF TWO DIFFERENT CONTAMINATING BACTERIA IN THESE THREE CASES MAKES A PRODUCT BATCH CONTAMINATION UNLIKELY. BOTH ISOLATED BACTERIA ARE SKIN/HAIR FOLLICLE CONTAMINANTS AND POINT TOWARDS A SURGICAL CONTAMINATION. NEVERTHELESS, EVEN IF THE IMPLANT WOULD HAVE BEEN NON-CONTAMINATED UNTIL ITS SURGICAL HANDLING AND APPLICATION, DUE TO THE KNOWN CHARACTERISTIC OF ANY IMPLANTABLE COLLAGEN (LOT AND PRODUCT INDEPENDENT) TO POTENTIALLY AUGMENT THE INFECTIOUS RESPONSE TO CONTAMINATION, WE CANNOT RULE OUT THAT THE PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED INFECTIOUS COMPLICATION. BAXTER HAS IDENTIFIED THAT THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE FOR THE REPORTED LOT IN THE PAST. THE ADDITIONAL INFORMATION IS CURRENTLY BEING EVALUATED AND THE INVESTIGATION IS CURRENTLY UNDERWAY AT THE MANUFACTURING FACILITY. BAXTER HAS SENT AN EMAIL TO (B)(4), FDA MDR ANALYST, REQUESTING THE RESULTS OF SAMPLE TESTING BY THE FDA. UPON THE COMPLETION OF THE INVESTIGATION A FOLLOW-UP SUBMISSION WILL BE SENT.

    Description of Event or Problem · 1

    HOLD KR. AN EVENT WAS RECEIVED FROM (B)(6) MEDICAL CENTER STATING THAT A PATIENT EXPERIENCED AN INFECTION AFTER A CRANIOTOMY IN WHICH DURA-GUARD WAS UTILIZED. THIS WAS A MALE PATIENT (B)(6). THE IMPLANT DATE OF THE PRODUCT WAS (B)(6) 2012 AND EXPLANT DATE OF (B)(6) 2013. (B)(6) WAS IDENTIFIED AFTER EXPLANT. THE DURATION OF SURGERY WAS APPROX. 2HRS. THIS IS THE THIRD CASE REPORTED FROM THIS USER FACILITY FOR THIS LOT. BAXTER RECEIVED USER FACILITY MEDWATCH REPORT #: (B)(4) ON (B)(4) 2013 FROM THE FDA THAT CONTAINED THE INITIAL TWO CASES. FOR REFERENCE PURPOSES HERE ARE THE PREVIOUS 2 REPORTED CASES: BAXTER COMPLAINT NUMBER (B)(4) THAT WAS RECEIVED ON (B)(4) 2013; MDR NUMBER 2032282-2013-00007 (B)(4); BAXTER COMPLAINT NUMBER (B)(4) THAT WAS RECEIVED ON (B)(4) 2013; MDR NUMBER 2032282-2013-00008 (B)(4). ADDITIONAL COMMUNICATION WITH THE REPORTING SITE ((B)(6)) AND EPIDEMIOLOGISTS EMPLOYED AT THE HOSPITAL ON (B)(6) 2013: IN THEIR INVESTIGATION THEY NOTED THE FIRST 2 CASES (BAXTER COMPLAINT NUMBERS: (B)(4)) GREW THE SAME P ACNES, WERE DONE BY THE SAME SURGEON, IN THE SAME OPERATING ROOM, AND SHARED TWO OTHER OR PERSONNEL IN COMMON. THE FIRST CASE WAS EXTENSIVE, LASTING 8 HOURS, WHILE THE SECOND CASE WAS SHORT, AND FINISHED IN 2 HOURS. THE THIRD CASE (BAXTER COMPLAINT NUMBER: (B)(4)) WAS SIMILAR IN THAT THE PATIENT RETURNED AFTER DISCHARGE COMPLAINING OF PHOTOPHOBIA, UNDERWENT MRI, REOPERATION AND WAS FOUND TO HAVE A PUS COLLECTION DIRECTLY UNDER THE DURA GUARD PATCH. THIS PATIENT HOWEVER GREW (B)(6), WAS OPERATED ON BY A DIFFERENT SURGEON, IN A DIFFERENT O.R. THEATRE, USING DIFFERENT PERSONNEL, AND THAT PATIENT WAS AN EMERGENT CLOSED TRAUMA CASE, NOT A SLATED PROCEDURE. THE OTHER COMMONALITY IS THAT ALL 3 PATIENTS HAD THE SAME LOT NUMBER OF DURA GUARD (5803443-1854262). THE HOSPITAL HAS USED 7 PATCHES OF THIS LOT NUMBER, THE OTHER 4 CASES HAD NO ISSUES. BAXTER ASKED IF THE HOSPITAL STILL HAD ANY UNITS FROM THE SAME LOT NUMBER IN STOCK AND WAS INFORMED THAT AT THE REQUEST OF THE FDA, THEY SENT THE REMAINING UNITS TO FDA FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22705 DURA-GUARD PERICARDIUM WITH APEX PROCESSING DURA SUBSTITUTE GXQ SYNOVIS SURGICAL INNOVATIONS 5803443-1854262

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other