BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 14959581 · Received July 8, 2022

    Report

    Report Number
    2024168-2022-07386
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    September 9, 2020
    Report Date
    August 23, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ¿ ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. DATE OF IMPLANT ¿ ESTIMATED. THE CLIP WAS NOT REPORTED AS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER ADVERSE EVENTS POSSIBLY RELATED TO THE STEERABLE GUIDE CATHETER ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ARTICLE ATTACHED TITLED: "TWO CASES OF MITRAL VALVE REPLACEMENT AFTER MITRACLIP FOR ATRIAL FMR¿ IS ONLY AVAILABLE IN JAPANESE. DETAILS WERE PROVIDED BY ABBOTT JAPAN AFFILIATES. THE OTHER CASE REFERENCED IN THE ATTACHED ARTICLE TITLE WERE FILED UNDER MEDWATCH REPORTS 2024168-2020-07719-01 AND 2024168-2020-07719-00.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. THE REPORTED PATIENT EFFECTS OF HEART FAILURE AND MITRAL REGURGITATION (MR), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). BASED ON THE INFORMATION PROVIDED, THE MR AND SUBSEQUENT HEART FAILURE APPEAR TO BE RELATED TO THE SLDA. THE HOSPITALIZATION AND SURGICAL PROCEDURE WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS THE PATIENT AS THE PATIENT REMAINED HOSPITALIZED AND SURGICAL INTERVENTION WAS PERFORMED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B3: DATE OF EVENT B5: EVENT DESCRIPTION. D6A: DATE OF IMPLANT.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT. A CASE REPORT WAS REPORTED VIA LITERATURE THAT A MITRACLIP PROCEDURE WAS PERFORMED ON A PATIENT WITH SEVERE FUNCTIONAL MITRAL REGURGITATION (MR). A MITRACLIP HAD BEEN IMPLANTED. IMMEDIATELY POST-PROCEDURE, THE MR REMAINED AS THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). CARDIAC INSUFFICIENCY SYMPTOMS WERE OBSERVED, REQUIRING HOSPITAL ADMISSION. 71 DAYS FOLLOWING THE MITRACLIP PROCEDURE, SURGICAL INTERVENTION WAS PERFORMED, INCLUDING A MITRAL VALVE REPLACEMENT, PROPHYLACTIC TRICUSPID ANNULOPLASTY (TAP), LEFT ATRIAL APPENDAGE CLOSURE, AND ATRIAL SEPTAL FORAMEN CLOSURE, LEAVING THE PATIENT IN GOOD CONDITION. PLEASE SEE ATTACHED ARTICLE FOR COMPLETE INFORMATION. "TWO CASES OF MITRAL VALVE REPLACEMENT AFTER MITRACLIP FOR ATRIAL FMR¿ IS ONLY AVAILABLE IN JAPANESE. DETAILS WERE PROVIDED BY ABBOTT JAPAN AFFILIATES.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: A CASE REPORT WAS REPORTED VIA LITERATURE THAT ON (B)(6) 2020, A MITRACLIP PROCEDURE WAS PERFORMED ON A PATIENT WITH SEVERE FUNCTIONAL MITRAL REGURGITATION (MR). TWO MITRACLIPS (CDS0502, 00210U180, 00210U177) WERE IMPLANTED. ON (B)(6) 2020, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS NOTED WITH ONE OF THE TWO MITRACLIPS (CDS0502, 00210U180). THE TAP PROCEDURE PERFORMED WAS A THORACOTOMY, NOT TRICUSPID ANNULOPLASTY. THAT SAME DAY ON (B)(6) 2020, THE MITRACLIPS WERE EXPLANTED DURING THE MITRAL VALVE REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2845860 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM NT VALVE REPAIR NKM ABBOTT MEDICAL 00210U180

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Disability| R| H