BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE FIXATION

    MDR report key: 3800531 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11293
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    June 25, 2012
    Report Date
    March 20, 2014
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: JOURNAL OF CARDIOTHORACIC SURGERY JUNE 25, 2012, 7:59. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR 1 UNKNOWN ZIP FIX CABLE TIE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THIS DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS. 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 SYSTEM: DESCRIPTION OF THE DEVICE, TECHNIQUE OF IMPLANTATION AND FIRST CLINICAL EVALUATION MARTIN TR GRAPOW, LUDOVIC F MELLY, FRIEDRICH S ECKSTEIN AND OLIVER T REUTHEBUCH, GRAPOW ET AL. JOURNAL OF CARDIOTHORACIC SURGERY 2012, 7:59. THE STUDY REGARDED 50 PATIENTS (22 FEMALES AND 28 MALE WITH THE MEAN AGE OF 67 YEARS) WERE CLOSED WITH THE ZIPFIX SYSTEM. NO STERNAL INSTABILITY WAS OBSERVED AT 30 DAYS. ONE PATIENT DIED AT DAY 14 DUE TO SEPTIC SHOCK OF ABDOMINAL ORIGIN, UNRELATED TO THE STERNAL CLOSURE. CLINICAL EXAMINATION CONFIRMED STERNAL STABILITY IN ALL PATIENTS AT DISCHARGE FROM THE HOSPITAL AND IN 47/49 AT 30 DAYS POSTOPERATIVELY. TWO PATIENTS DEVELOPED MEDIASTINITIS THAT NECESSITATED REMOVAL OF THE ZIPFIX AT DAY 24 AND 30 IN ASSOCIATION WITH ADMINISTRATION OF ANTIBIOTICS HOWEVER, BOTH STERNA WERE STABLE AND ALL ZIPFIX WERE INTACT. BOTH PATIENTS WERE SUFFERING FROM METABOLIC SYNDROME WITH A BMI OF 40 AND 35 RESPECTIVELY, AS WELL AS INSULIN-DEPENDENT DIABETES AND CHRONIC RENAL FAILURE UNDER HEMODIALYSIS. POSTOPERATIVELY, 2 FEMALE PATIENTS HAD TO BE MECHANICALLY RESUSCITATED. IN THE FIRST CASE AT DAY 3 THE PATIENT RECEIVED 2 SHOCKS OF 200 J FOR A VENTRICULAR FIBRILLATION DURING THE 10 MINUTES RESUSCITATION. IN THE SECOND CASE THE PATIENT SHOWED AN ASYSTOLE AT DAY 19 AND WAS REANIMATED DURING 35 MINUTES. EVEN THOUGH OSTEOPOROTIC, BOTH STERNA REMAINED STABLE. SHORT-TERM RESULTS DEMONSTRATED, IN A SMALL GROUP OF PATIENTS, THE SAFE AND EFFECTIVE USE OF THE STERNAL ZIPFIX SYSTEM. IT IS FAST, REPRODUCIBLE, EASY TO USE AND HAS GREAT POTENTIAL FOR BEING AN ALTERNATIVE FOR TRADITIONAL WIRE CLOSURE. THIS COMPLAINT IS FOR THE TWO PATIENTS WHO SUFFERED MEDIASTINITIS. THIS REPORT IS FOR AN UNKNOWN ZIPFIX IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277977 CERCLAGE FIXATION JDQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R