BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4232618 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07260
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    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. CONCOMITANT MEDICAL PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP (10317555/08). 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 INCLUDE, 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 CONDITIONS, 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. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS AND NOT A PRODUCT QUALITY DEFICIENCY. THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE (MITRAL VALVE INJURY) AND WORSENING MR AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED SLDA CLIP IS LIKELY CONTRIBUTORY TO THE OBSERVED INCREASE IN MR AND TISSUE DAMAGE; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DATABASE INDICATED THERE HAVE BEEN NO OTHER INCIDENTS OF SINGLE LEAFLET DEVICE ATTACHMENT 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 IMPLANTED CLIP DETACHED FROM ONE LEAFLET AND REMAINED SECURELY ATTACHED TO THE OTHER LEAFLET. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THERE WAS A POSTERIOR LEAFLET PROLAPSE. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 1-2. ON (B)(6) 2014, THE PATIENT CAME TO THE CLINIC FOR AN ECHO CONTROL AND IT WAS FOUND THAT THE MEDIAL CLIP HAD DETACHED FROM THE ANTERIOR LEAFLET, AND REMAINED ON THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE MR HAD INCREASED TO 4 AND THE PHYSICIAN BELIEVES IT IS POSSIBLE THAT THE ANTERIOR LEAFLET WAS DAMAGED. ON (B)(6) 2014, AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED TO STABILIZE THE DETACHED CLIP AND REDUCE THE MR. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 2. IT WAS NOTED THAT THERE WAS A RESIDUAL JET LEFT BETWEEN THE IMPLANTED CLIPS, BUT THE SPACE BETWEEN THESE CLIPS IS TOO SMALL TO IMPLANT AN ADDITIONAL CLIP. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714730 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10321575

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention