BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3900250 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04167
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).(B)(6). THE MITRACLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CDS. THE REPORTED PATIENT EFFECTS OF WORSENING MR AND DYSPNEA, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. IT WAS CONFIRMED BY THE PHYSICIAN THAT THE DEVICE AND THE PROCEDURE DID NOT CONTRIBUTE TO THE INCREASED MR AND THE ASSOCIATED DYSPNEA. BASED ON THE INFORMATION REVIEWED, THE REPORTED MR AND DYSPNEA APPEAR TO BE RELATED TO PATIENT CONDITIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED AS AFTER THE CLIP WAS IMPLANTED ON (B)(6) 2009, THE PATIENT EXPERIENCED RECURRENT MITRAL REGURGITATION (MR) AND ANOTHER MITRACLIP PROCEDURE WAS PERFORMED. THE CAUSE OF THE RECURRENT MR WAS NOT REPORTED AND THE IMPLANTED CLIP CANNOT BE EXCLUDED AS POSSIBLY CONTRIBUTORY TO THE INCREASE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2009 AND ONE CLIP WAS IMPLANTED. AFTER IMPLANTATION, THE CLIP HAD DETACHED FROM ONE LEAFLET AND A SECOND MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2009. THE FUNCTIONAL MR GRADE WAS REDUCED TO 1 AND WAS CONSIDERED AS A REASONABLE OUTCOME. DURING THE SUBSEQUENT YEARS, THE PATIENT'S EJECTION FRACTION INCREASED FROM 15 TO GREATER THAN 40 PERCENT. THE PATIENT RECEIVED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRTD) DUE TO VENTRICULAR TACHYCARDIA. IN THE PAST FEW MONTHS, THE PATIENT EXPERIENCED DYSPNEA AND WAS ADMINISTERED OPTIMAL MEDICAL TREATMENT; HOWEVER, IN (B)(6) 2014, THE PATIENT COULD NOT TOLERATE THE SYMPTOMS. A REGURGITANT JET WAS FOUND BETWEEN THE FIRST AND SECOND CLIP WITH A GRADE OF 3-4. ANOTHER MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014. ONE CLIP WAS IMPLANTED IN THIS JET REDUCING THE MR GRADE TO 2. AS THERE WAS NO SPACE FOR A 4TH CLIP, THE PROCEDURE WAS CONCLUDED AND THE PHYSICIAN WAS SATISFIED WITH THE MR GRADE OF 2 AND A MEAN GRADIENT PRESSURE OF 5. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION INDICATED THAT THE VENTRICULAR TACHYCARDIA AND DYSPNEA WITH INCREASED MITRAL REGURGITATION (MR) WERE NOT RELATED TO THE MITRACLIPS OR THE CLIP PROCEDURE. IN THE PHYSICIAN OPINION, THE INCREASED MR WAS DUE TO DISEASE PROGRESSION. THE PREVIOUSLY TWO IMPLANTED CLIPS WERE STABLE IN THEIR PREVIOUS LOCATIONS ON THE LEAFLET. IT WAS NOT ANATOMICALLY POSSIBLE TO PLACE A 4TH CLIP. THE PATIENT WAS CLINICALLY STABLE POST PROCEDURE ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376370 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R MITRACLIP (X1)