BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4210913 · Received October 29, 2014

    Report

    Report Number
    2024168-2014-07091
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION CAN BE CAUSED BY, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE/PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS) OR MANUFACTURING ANOMALIES. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE SLDA MAY BE INFLUENCED BY THE DIFFICULTIES WITH VISUALIZATION OR MORPHOLOGY OF THE MITRAL VALVE, INCLUDING TETHERING OF THE LEAFLETS, CHORDAE INTERACTION, OR LEAFLETS THAT ARE THINNER/THICKER, RESTRICTED AND PROLAPSED. IN THIS CASE THERE WAS A P2 LEAFLET FLAIL AND CHORDAL RUPTURE DUE TO PROGRESSION OF THE DISEASE. THE REPORTED SLDA OF THE ANTERIOR LEAFLET WAS LIKELY DUE TO PROGRESSION OF THE DISEASE; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED SLDA CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A QUALITY DEFICIENCY ASSOCIATED WITH BOTH DEVICES. THE REPORTED PATIENT EFFECTS OF MITRAL REGURGITATION (WORSENING), DYSPNEA AND ARRHYTHMIA ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD FOR BOTH IMPLANTED CLIPS REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR SLDA INCIDENTS REPORTED FOR THIS LOT BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THAT THE CLIP DETACHED FROM ONE LEAFLET AND REMAINED SECURELY ATTACHED TO THE OTHER LEAFLET AND REQUIRED AN ADDITIONAL MITRACLIP PROCEDURE. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2012 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS (CDS02ST 10140800/28 AND 10140800/30) WERE IMPLANTED AND THE MR WAS REDUCED TO 1-2. ON (B)(6) 2014, THE PATIENT PRESENTED WITH DYSPNEA AND PALPITATIONS. DURING THE BASAL ECHOCARDIOGRAM EVALUATION, IT WAS OBSERVED THAT ONE OF THE IMPLANTED CLIPS DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED SECURELY ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE MR HAD INCREASED TO 4. IT WAS OBSERVED THAT THERE WAS A POSTERIOR FLAIL AND CHORDAL RUPTURE THAT WAS DUE TO THE DISEASE. AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO TREAT THE SLDA AND THE INCREASED MR GRADE. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 1. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693322 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10140800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 1 IMPLANTED MITRACLIP