BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3942564 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04611
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP. THE REPORTED PATIENT EFFECTS OF ANGINA, ATRIAL FIBRILLATION, DYSPNEA, WORSENING MITRAL REGURGITATION, AND HEART FAILURE, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS MITRACLIP REPORT IS BEING FILED FOR THE RECURRENT MITRAL REGURGITATION (MR) AND INCREASED HEART FAILURE, WHICH ARE CONSIDERED SERIOUS INJURIES. IT WAS REPORTED THAT ON (B)(6) 2013 ONE MITRACLIP WAS IMPLANTED IN THE PATIENT WITH FUNCTIONAL MR REDUCING THE MR FROM 3+ TO 1+. THIS PATIENT HAD A HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION PRIOR TO THE CLIP PROCEDURE WITH TWO CARDIOVERSIONS. ON (B)(6) 2014, THE ATRIAL FIBRILLATION WORSENED TO PERSISTENT AND THE PATIENT WAS HOSPITALIZED. AT THE TWELVE MONTH FOLLOW-UP VISIT FOR THE CLIP PROCEDURE, ON (B)(6) 2014, THE PATIENT HAD INCREASED CONGESTIVE HEART FAILURE AND SEVERE MR. THE PATIENT WAS HOSPITALIZED FOR AN ELECTIVE CARDIOVERSION AND CRYOABLATION PULMONARY VEIN ISOLATION PROCEDURE TO TREAT THE ATRIAL FIBRILLATION. ON (B)(6) 2014, THE PATIENT REPORTED HAVING MORE CHEST PAIN AND SHORTNESS OF BREATH TREATED WITH MEDICATION. THE STUDY PHYSICIAN INDICATED THESE REPORTED PATIENT EVENTS ARE UNRELATED TO THE CLIP PROCEDURE. THE STUDY PHYSICIAN INDICATED IT IS UNKNOWN IF THE CLIP IS RELATED TO THESE REPORTED PATIENT EVENTS; HOWEVER, THE CLIP REMAINS ATTACHED TO BOTH LEAFLETS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SECOND CLIP PROCEDURE ON (B)(6) 2014 AND MITRAL REGURGITATION WAS REDUCED FROM 4 TO 1+ WITH ONE MITRACLIP. CARDIOVERSION WAS PERFORMED ON (B)(6) 2014 FOR THE ATRIAL FIBRILLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION INDICATED: A HEART RHYTHM STRIP FROM (B)(6) 2014 FOUND THAT THE PATIENT'S HEART RHYTHM REVERTED BACK TO ATRIAL FIBRILLATION. THE STUDY PHYSICIAN INDICATED IT IS UNKNOWN IF THE CLIP IS RELATED TO THIS RECURRENT ATRIAL FIBRILLATION. THE PATIENT WAS HOSPITALIZED AND CRYOABLATION WAS PERFORMED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418087 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10252725

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R