BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 5074489 · Received September 14, 2015

    Report

    Report Number
    2024168-2015-05303
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 14, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS AND COMPLAINT HISTORY. THE INVESTIGATION DETERMINED THAT THE REPORTED SLIPPAGE OF THE DEVICE AND PHYSICAL RESISTANCE APPEAR TO BE RELATED TO USER TECHNIQUE AND PATIENT ANATOMY. THE REPORTED PATIENT EFFECT OF ATRIAL PERFORATION IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED ATRIAL PERFORATION APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE, OR LABELING.

    Description of Event or Problem · 1

    THIS EVENT IS BEING FILED BECAUSE THE STEERABLE GUIDE CATHETER (SGC)SLIPPED OUT OF POSITION AND A SHUNT WAS NOTED, WHICH REQUIRED ADDITIONAL TREATMENT TO PREVENT PERMANENT IMPAIRMENT TO THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2015 WAS TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE FIRST CLIP WAS DEPLOYED WITHOUT ISSUE, REDUCING MR TO 1-2. DURING POSITIONING OF THE SECOND CLIP DELIVERY SYSTEM (CDS), THE STABILIZER WAS MOVED TO BRING THE CDS CLOSER TO THE DEPLOYED CLIP; HOWEVER, AFTER THIS MANEUVER, THE STEERABLE GUIDE CATHETER (SGC) SLIPPED FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM. ATTEMPTS TO REPOSITION THE SGC BACK INTO THE LEFT ATRIUM WERE UNSUCCESSFUL; THEREFORE, THE CDS WAS RETRACTED BACK INTO THE SGG AND THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. A SHUNT WAS THEN NOTED AT THE SEPTUM, WHICH COULD NOT BE TREATED AS THERE WAS NO APPROPRIATELY SIZED TREATMENT DEVICE AVAILABLE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND THE SHUNT WAS TREATED THE FOLLOWING DAY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606730 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 41126U209

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R OTHER: CLIP DELIVERY SYSTEM