BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 10886159 · Received November 23, 2020

    Report

    Report Number
    2024168-2020-09808
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    November 3, 2020
    Report Date
    February 23, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUES COULD NOT BE TESTED VIA RETURNED DEVICE ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT IDENTIFY ANY OTHER INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF MITRAL REGURGITATION (MR) AND FOREIGN BODY IN PATIENT, AS LISTED IN THE MITRACLIP G4 CLIP DELIVERY SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A DEFINITIVE CAUSE FOR THE REPORTED ISSUES OF CLIP OPEN ¿ ESTABLISHING FINAL ARM ANGLE (EFAA), CLIP OPEN ¿ LOCKED AND CLIP OPEN INABILITY ¿ ANATOMY COULD NOT BE DETERMINED IN THIS CASE. ENTRAPMENT OF DEVICE APPEARS TO BE A RESULT/ CASCADING EFFECT OF TROUBLESHOOTING PROCEDURES. THE FOREIGN BODY IN PATIENT (THE CLIP WAS DEPLOYED ON THE POSTERIOR LEAFLET) AND THE MR IS A RESULT/ CASCADING EFFECTS OF ENTRAPMENT OF THE DEVICE (CLIP GETTING CAUGHT). BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: THE INDEX MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2020. AN XTW (MITRACLIP CDS0701-XTW 00217U141) HAD BEEN SUCCESSFULLY IMPLANTED. DURING THE SECOND PROCEDURE ON (B)(6) 2020, CDS0701-NTW / 00623U532 WAS DEPLOYED. FULLY CLOSED ON THE POSTERIOR LEAFLET, WITHOUT THE ANTERIOR LEAFLET. THE CLIP REMAINED STABLE AT THIS LOCATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL NTW MITRACLIP DEVICE REFERENCED IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS THE CLIP OPENED MORE THAN EXPECTED POST-DEPLOYMENT, THE CLIP ARMS LOCKED, AND THE CLIP WAS DEPLOYED IN AN UNINTENDED AREA. IT WAS REPORTED THAT THE FIRST MITRACLIP PROCEDURE WAS PERFORMED ON AN UNSPECIFIED DATE FOR DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4 WITH A MEDIAL FLAIL. AN XTW MITRACLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR FROM GRADE 4 TO 1. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A SECOND MITRACLIP PROCEDURE DUE TO RECURRENT MR, GRADE 3. REPORTEDLY, THE INITIAL XTW CLIP HAD REMAINED STABLE AND WELL SEATED, WITH NO TISSUE INJURY REPORTED, NO DEVICE ISSUE, AND THE RECURRENT MR WAS DUE TO DISEASE PROGRESSION. THE FIRST CLIP DELIVERY SYSTEM (CDS0701-NTW, 00521U129) GRASPED MEDIAL TO THE XTW. PER INSTRUCTIONS FOR USE (IFU), FINAL ARM ANGLE (FAA) WAS PERFORMED, HOWEVER, THE CLIP HAD OPENED TO 60 DEGREES AND FAILED THE FAA. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CLIP WAS CLOSED, LOCK LEVER CHECKED AND FULLY ADVANCED, AND ANOTHER FAA WAS ATTEMPTED. AGAIN, THE CLIP OPENED TO 60 DEGREES ON FAA. MORE STANDARD TROUBLESHOOTING WAS PERFORMED, UNLOCKED AND RE-LOCKED CLIP, THE CLIP WAS CLOSED BACK DOWN, WENT THROUGH THE STEPS AGAIN, HOWEVER, THE CLIP WAS UNABLE TO PASS FAA. IT WAS DECIDED TO NOT DEPLOY THE CLIP AND THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO TISSUE INJURY OBSERVED. ANOTHER MITRACLIP (CDS0701-NTW, 00623U532) WAS PLACED AT THE SAME POSITION, MEDIAL TO THE PREVIOUSLY IMPLANTED XTW. PER IFU, ANOTHER FAA WAS PERFORMED, HOWEVER, THE CLIP HAD OPENED TO 30 DEGREES AND FAILED THE FAA. STANDARD TROUBLESHOOTING WAS PERFORMED, HOWEVER THE CLIP FAILED FAA AGAIN AS IT RELAXED TO 30 DEGREES. FAA WAS ATTEMPTED ONE MORE TIME AND THIS TIME THE CLIP PASSED AND DEPLOYMENT CONTINUED. THE LOCK LINE WAS REMOVED WITHOUT RESISTANCE NOTED WHEN THE CLIP OPENED TO 60 DEGREES. THE OPERATOR CLOSED THE CLIP BACK DOWN AND THEN ATTEMPTED TO RE-OPEN TO 120 DEGREES, INVERT, AND REMOVE THE CLIP. THE CLIP HOWEVER, WAS STUCK ON THE POSTERIOR LEAFLET. STANDARD TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP REMAINED STUCK ON THE POSTERIOR LEAFLET. TO PREVENT LEAFLET TEARING, IT WAS DECIDED TO DEPLOY THE CLIP. THE CLIP WAS ATTEMPTED TO RE-GRASP THE ANTERIOR LEAFLET WHEN THE CLIP LOCKED POSITION AT 60 DEGREES AND THE CLIP ARMS WERE UNABLE TO OPEN ANYMORE. THE CLIP WAS DEPLOYED ON THE POSTERIOR LEAFLET, WITHOUT THE ANTERIOR. NO OTHER CLIP WAS ATTEMPTED. THE MR REMAINED GRADE 3. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350338 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NTW 00623U532 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 1 MITRACLIP| STEERABLE GUIDE CATHETER| 1 MITRACLIP| STEERABLE GUIDE CATHETER