BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3830880 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03317
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS ESTIMATED THAT APPROXIMATELY 80% OF THIS PATIENT'S MITRAL VALVE WAS ON THE ANTERIOR LEAFLET, WHICH MAY HAVE CONTRIBUTED TO THIS DETACHMENT. TYPICALLY, THE ANTERIOR MITRAL VALVE IS 2/3 OF THE ENTIRE VALVE, AND THE POSTERIOR LEAFLET IS TYPICALLY 1/3 OF THE VALVE. THE PATIENT IS STILL FEELING AND DOING WELL ON (B)(6) 2014. THERE HAVE BEEN NO WORSENING OF SYMPTOMS. THE PATIENT IS NOT A SURGICAL CANDIDATE, BUT A SECOND CLIP PROCEDURE IS BEING CONSIDERED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE CLIPS REMAIN IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER MITRACLIP REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR FAILURE TO ADHERE OR BOND TO THE LEAFLETS AND SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE AND PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS). AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL DEVICES ARE SUBJECT TO 100% VISUAL AND FUNCTIONAL INSPECTION TO VERIFY PRODUCT QUALITY. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP FUNCTIONED AS EXPECTED. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT, AND A REVIEW OF THE COMPLAINT DATABASE DID NOT INDICATE A MANUFACTURING ISSUE. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREP, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY GRASPING AND SLDA MAY BE INFLUENCED BY THE DIFFICULTIES WITH VISUALIZATION OR MORPHOLOGY OF THE MITRAL VALVE, INCLUDING TETHERING OF THE LEAFLETS, CHORDAE INTERACTION, OR LEAFLETS THAT ARE THINNER/THICKER, RESTRICTED AND PROLAPSED. THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT THIS WAS CHALLENGING CASE DUE TO PATIENT ANATOMY; THE PATIENT HAD A POSTERIOR LEAFLET THAT WAS AT A VERTICAL ANGLE. THE ANTERIOR LEAFLET WAS ALSO PROLAPSING OVER THE POSTERIOR LEAFLET. FURTHERMORE, IT WAS CHALLENGING TO IMAGE AND GRASP BOTH LEAFLETS, BUT THIS WAS DUE TO ANATOMY ITSELF AND NOT THE IMAGING DEVICE. IT WAS SURMISED THAT THE POSSIBLE CAUSE OF THE DETACHMENT MAY HAVE BEEN CHORD OR SMALL AMOUNT OF LEAFLET INSERTED IN THE CLIP. IN THIS CASE, IT IS LIKELY THAT A COMBINATION OF THE VERTICAL ANGLE OF THE POSTERIOR LEAFLET AND THE PROLAPSE OF THE ANTERIOR LEAFLET IN CONJUNCTION WITH A POSSIBLE INTERACTION WITH THE CHORDAE OR INADEQUATE LEAFLET INSERTION CONTRIBUTED TO THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION REVIEWED, THE REPORTED FAILURE TO ADHERE OR BOND/DIFFICULT GRASPING AND SLDA APPEAR TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT THERE WAS NO EVIDENCE OF A TORN LEAFLET ON THE (B)(6) 2014 ECHOCARDIOGRAM. HOSPITALIZATION WAS NOT PROLONGED DUE TO THE SINGLE LEAFLET DEVICE ATTACHMENT. THERE WAS NO EVIDENCE OF MYXOMATOUS DISEASE, NO EVIDENCE OF FIBROELASTIC DISEASE, NO KNOWN OR SUSPECTED CHORDAL PATHOLOGY, NO KNOWN OR SUSPECTED PAPILLARY MUSCLE PATHOLOGY.

    Description of Event or Problem · 1

    THIS MITRACLIP REPORT IS BEING FILED FOR THE SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT IT WAS KNOWN THAT THIS WAS GOING TO BE A CHALLENGING CASE DUE TO PATIENT ANATOMY IN THIS PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 3+. THE PATIENT HAD A POSTERIOR LEAFLET THAT WAS AT A VERTICAL ANGLE. THE ANTERIOR LEAFLET WAS PROLAPSING OVER THE POSTERIOR LEAFLET. IT WAS CHALLENGING TO IMAGE AND GRASP BOTH LEAFLETS, BUT THIS WAS DUE TO ANATOMY, NOT THE IMAGING DEVICE. AFTER THEY WERE ABLE TO GET A GRASP ON BOTH LEAFLETS WITH THE FIRST CLIP (SERIAL (B)(4)), LEAFLET INSERTION ASSESSMENT WAS PERFORMED. THE CLIP WAS DEPLOYED, AND THEN THE ANTERIOR LEAFLET CAME FREE OF THE CLIP. THE MR RETURNED TO BASELINE OF 3+. IT WAS SURMISED THAT THE POSSIBLE CAUSE OF THE DETACHMENT MAY HAVE BEEN CHORD OR SMALL AMOUNT OF LEAFLET INSERTED IN THE CLIP. THE DECISION WAS MADE TO PLACE A 2ND CLIP, SERIAL 15, ADJACENT TO FIRST CLIP. THE LEAFLETS WERE BOTH GRASPED, BUT IT WAS CHALLENGING TO DETERMINE HOW MUCH LEAFLET WAS IN THE CLIP, SO THE LEAFLETS WERE RELEASED, AND THEN GRASPED AGAIN. WHEN IT WAS FELT THAT THERE WAS REALLY GOOD INSERTION OF BOTH LEAFLETS, LEAFLET INSERTION WAS ASSESSED, AND THE SECOND CLIP WAS DEPLOYED WITHOUT ISSUE WITH AN MR OF 2+. THERE WERE NO ADVERSE PATIENT EFFECTS. AFTER THE PROCEDURE, THE PATIENT WAS FEELING GREAT AND WANTED TO GO HOME. THE DAY AFTER THE PROCEDURE, (B)(6) 2014, IT WAS REPORTED THAT THE SECOND CLIP DETACHED FROM THE POSTERIOR LEAFLET WITH AN MR OF 3+. IN THE PHYSICIANS OPINION, THE POSSIBLE CAUSE OF THIS SECOND DETACHMENT WAS THAT THERE WAS A SIGNIFICANT AMOUNT OF FORCE PULLING ON THE POSTERIOR LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307698 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10309135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention STEERABLE GUIDE CATH,LIFT,SUPPORT PLATE,STABILIZER