BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE

    MDR report key: 3956053 · Received July 24, 2014

    Report

    Report Number
    2520274-2014-12831
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    April 26, 2013
    Report Date
    March 20, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN ZIPFIX, UNKNOWN QUANTITY/UNKNOWN LOT . THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿A NEW CABLE-TIE-BASED STERNAL CLOSURE DEVICE: INFECTIOUS CONSIDERATIONS¿ (APRIL 26, 2013). MELLY, L., AND ET. AL. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 17 (2013) 219¿224. THE AUTHORS PERFORMED A RETROSPECTIVE DESCRIPTIVE AND COMPARATIVE STUDY AT A HOSPITAL WITH THE OBJECTIVE OF ASSESSING THE FREQUENCY OF WOUND INFECTION AND STERNAL DEHISCENCE POST-STERNOTOMY WITH REGARD TO THE CLOSURE TECHNIQUE ITSELF. TWO SENIOR SURGEONS STARTED TO USE THE STERNAL ZIPFIX (ZF) (SYNTHES (B)(4)) CLOSING DEVICE IN FEBRUARY 2011. HERE, WE COMPARE THE CONVENTIONAL CLOSURE WITH STAINLESS STEEL WIRES (COMPETITOR PRODUCT) WITH THE PEEK-BASED STERNAL ZF DEVICE WITH REGARD TO STERNAL INFECTIONS. THE AUTHORS COLLECTED ALL CARDIAC OPERATIONS PERFORMED VIA STERNOTOMY BETWEEN 1 FEBRUARY 2011 AND 31 JANUARY 2012. THE AUTHORS COMPARED 95 PATIENTS¿ WHOSE STERNUM WAS EXCLUSIVELY CLOSED WITH STERNAL ZF WITH 498 PATIENTS WHO WERE CLOSED WITH CONVENTIONAL WIRES (CWS). THE MEAN AGE OF THE WHOLE POPULATION WAS 66 YEARS, WITH 76% OF MALES. A TOTAL OF 36 PATIENTS DEVELOPED A STERNAL INFECTION IN A SAME GENDER PROPORTION AS THE OVERALL PROPORTION, WITH 27 MALES AND 9 FEMALES. COMORBIDITIES INCLUDED: DIABETES, DYSLIPIDEMIA, HYPERTENSION, SMOKING, CORONARY ARTERY DISEASE, PULMONARY DISEASE, RENAL IMPAIRMENT, AND NEUROVASCULAR DISEASE. TWO PATIENTS DIED. OF THE 2 PATIENTS WHO DIED WITHIN 30 DAYS IN THE ZF GROUP, ONLY 1 HAD DEVELOPED A STERNAL INFECTION EARLIER; THE OTHER DIED FROM A SEPSIS OF ABDOMINAL ORIGIN AND THE STERNUM WAS NEVER REOPENED. THERE IS NO MEDICAL EVIDENCE TO LINK THE SYNTHES DEVICES TO THE REPORTED DEATHS. IN THE ZIPFIX GROUP, 5 PATIENTS EXPERIENCED DEEP STERNAL INFECTIONS. OF THE 5 PATIENTS IN THE ZF GROUP WHO DEVELOPED AN INFECTION, 2 COULD KEEP THEIR STERNAL CLOSURE DEVICE IN PLACE AND ONLY A SUBCUTANEOUS DEBRIDEMENT WAS PERFORMED WITH SUCCESSFUL CLINICAL COURSE AFTERWARDS, 2 COULD BE CLOSED LATER AFTER A VACUUM-ASSISTED THERAPY WITH EITHER CW OR NEW ZF AND ONLY 1 NEEDED A COMPLEX CLOSURE WITH A PLATE OSTEOSYNTHESIS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN STERNAL ZIPFIX AND REFERS TO THE 5 PATIENTS WHO EXPERIENCED DEEP STERNAL INFECTIONS. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433243 CERCLAGE JDQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention