BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3973736 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04924
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS AND INFORMATION PROVIDED TO ABBOTT VASCULAR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE REPORTED PATIENT EFFECTS OF ARRHYTHMIA, DEATH, TISSUE DAMAGE (MITRAL-VALVE INJURY), AND HEART FAILURE (WORSENING), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. IN THIS CASE, THE TISSUE DAMAGE WAS ATTRIBUTED TO PROCEDURAL CONDITIONS DURING POSITIONING OF THE THIRD CLIP, WHICH RESULTED IN THE INCREASE IN MITRAL REGURGITATION (MR). AS A RESULT OF THE MR INCREASE, THE DECISION WAS MADE TO IMPLANT THE IMPELLA DEVICE, WHICH RESULTED IN THE SUBSEQUENT EFFECTS OF ARRHYTHMIA, HEART FAILURE, AND PATIENT DEATH. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE MITRAL VALVE IS CONSTRUCTED SUCH THAT THERE ARE CHORDAE, OR FINGERLIKE PROJECTIONS, EXTENDING FROM THE PAPILLARY MUSCLES OF THE LEFT VENTRICULAR WALL AND ATTACH TO THE UNDERSIDE OF THE TWO MITRAL LEAFLETS. THE CHORDAE WORK IN CONJUNCTION WITH THE PAPILLARY MUSCLES AND LEFT VENTRICLE ITSELF TO FACILITATE CLOSURE OF THE MITRAL VALVE DURING SYSTOLE IN ORDER TO PREVENT BLOOD FLOW BACK INTO THE LEFT ATRIUM. THE CHORDAE ATTACH MAINLY AT THE COMMISSURES OF THE VALVE WHERE THE LEAFLETS MEET. IN THE SETTING OF FUNCTIONAL MR, LEFT VENTRICULAR DYSFUNCTION RESULTS IN INCOMPLETE CLOSURE OF THE MITRAL VALVE GIVEN THIS INTERRELATED NETWORK OF STRUCTURES. IT WAS SUSPECTED THAT DURING PLACEMENT OF THE THIRD CLIP THERE MAY HAVE BEEN POTENTIAL CHORDAL ENTANGLEMENT CONTRIBUTING TO THE RUPTURE AND FLAIL. THIS POTENTIAL INTERACTION IS NOT RELATED TO A DEVICE DEFICIENCY OR MALFUNCTION BUT MORE LIKELY DUE TO UNDERLYING PATHOLOGY OF THE DISEASE. THE SUBSEQUENT INTERVENTION OF IMPELLA IMPLANTATION DUE TO LEFT VENTRICULAR FAILURE AND DEATH ARE NOT REFLECTIVE OF A DEVICE DEFICIENCY OR MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). UNCHANGED MITRAL REGURGITATION GRADE. THE MITRACLIP REMAINED IMPLANTED ON THE MITRAL VALVE LEAFLETS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION INDICATED THAT DURING POSITIONING OF THE THIRD CLIP, THERE WAS NO RESISTANCE FELT THAT MIGHT HAVE INDICATED THAT THE DEVICE WAS ENTANGLED IN THE CHORDAE. AT THE TIME OF DEATH, THE PATIENT WAS STILL HOSPITALIZED. THE CAUSE OF DEATH WAS INGRAVESCENT RIGHT HEART FAILURE. THE TREATMENT WITH IMPELLA CAUSED VENTRICULAR ARRHYTHMIAS THAT LED TO THE DEATH. AT THE TIME OF DEATH, THE MITRAL REGURGITATION (MR) GRADE WAS 3+. IN THE OPINION OF THE PHYSICIAN, THE IMPLANTED CLIPS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. IN THE OPINION OF THE PHYSICIAN, THE CHORDAE RUPTURE AND POST PROCEDURE MR GRADE (3+) DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. HOWEVER, THE MITRACLIP PROCEDURE CONTRIBUTED TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS FILED FOR THE CLIP DELIVERY SYSTEM (10349725/(B)(4)) AS A CHORDAL RUPTURE AND FLAIL WERE OBSERVED POST PROCEDURE AND WAS THOUGHT TO POSSIBLY HAVE BEEN CAUSED WHILE POSITIONING THE THIRD CLIP. THE INCREASED MITRAL REGURGITATION GRADE WAS MEDICALLY TREATED. THE PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE CAUSE OF DEATH WAS NOT REPORTED, THEREFORE, THE RELATIONSHIP OF DEATH TO THE IMPLANTED CLIP CANNOT BE EXCLUDED. IT WAS REPORTED THAT PRIOR TO (B)(6) 2014 MITRACLIP PROCEDURE, THE PATIENT WAS SCREENED WITH A TRANSESOPHAGEAL ECHOCARDIOGRAM AND WAS CONSIDERED TECHNICALLY FEASIBLE TO UNDERGO THE PROCEDURE. THREE MITRACLIPS (10349725/(B)(4), 10338475/(B)(4),10349725/(B)(4)) WERE IMPLANTED IN THE A2-P2 SEGMENT OF THE MITRAL VALVE REDUCING THE FUNCTIONAL MITRAL REGURGITATION (MR) GRADE FROM 4+ TO 2+. NO ISSUES WERE OBSERVED DURING THE PROCEDURE. TWENTY MINUTES POST PROCEDURE, THE MR WORSENED TO 4+. THE TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED A CHORDAL RUPTURE WITH A FLAIL OF THE LATERAL PART OF THE A2/A1 SEGMENT OF THE ANTERIOR LEAFLET. PER THE PHYSICIAN, THE RUPTURE OF THE CHORDAE MAY HAVE OCCURRED DURING THE POSITIONING OF THE THIRD CLIP. DUE TO THE MR GRADE, THE PATIENT WAS ADMINISTERED MAXIMUM INOTROPE SUPPORT AND UNDERWENT AN IMPELLA PROCEDURE. ON (B)(6) 2014, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451283 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10349725

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MITRACLIP (X2)