BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3854294 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03645
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, 2 IMPLANTED; MITRACLIPS (10325055/12, 10321615/03). THE ADDITIONAL DEVICE REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. POTENTIAL CAUSES FOR THE REPORTED DEVICE DAMAGING ANOTHER DEVICE 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 ORIENTATION OF THE CLIP UPON INSERTION). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE DEVICE DAMAGING ANOTHER DEVICE MAY BE INFLUENCED BY TENSION ON THE DEVICE, STEERING DIFFICULTIES, PATIENT ANATOMY, OR MULTIPLE CLIPS PRESENT AT THE DEPLOYMENT SITE. BASED ON THE INFORMATION REVIEWED, IT IS LIKELY THAT THE THIRD CLIP COMING INTO CONTACT WITH THE SECOND CLIP (CAUSING DAMAGE TO ANOTHER DEVICE) WAS A RESULT OF PROCEDURAL CONDITIONS / POSITIONING OF THE PREVIOUSLY IMPLANTED CLIP, AND IS NOT A PRODUCT QUALITY DEFICIENCY. AFTER IMPLANTATION OF THE THIRD CLIP, THE MR GRADE REMAINED THE SAME. A JET REMAINED BETWEEN CLIP 1 AND CLIP 2, WHICH MAY BE THE CAUSE FOR THE UNCHANGED MR. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND ITS RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE MANUFACTURING, DESIGN, OR LABELING OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A SIMILAR ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT DAMAGE TO A PREVIOUSLY IMPLANTED CLIP WHICH WAS CAUSED BY THIS CLIP (10330785/01) AND RESULTED IN AN UNCHANGED MITRAL REGURGITATION (MR) GRADE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MR WITH A GRADE OF 3-4. CLIP 1 (10325055/12) WAS IMPLANTED AND THE MR GRADE WAS REDUCED TO 3. DIFFICULTY WAS NOTED DURING PLACEMENT DUE TO A SHORT POSTERIOR MEDICAL LEAFLET (PML). NEXT, CLIP 2 (10321615/03) WAS IMPLANTED AND THE MR GRADE WAS REDUCED TO 2. THE THIRD CLIP DELIVERY SYSTEM (CDS 10330785/01) WAS ADVANCED; HOWEVER, THIS CLIP 3 CAME IN CONTACT WITH THE IMPLANTED CLIP 2, AND THE CLIP 2 DETACHED FROM THE PML, AND REMAINED ON THE ANTERIOR LEAFLET. AFTER CLIP 2 DETACHED, THE MR GRADE INCREASED TO 4. THERE WAS NO LEAFLET DAMAGE. THE SAME CLIP 3 WAS THEN IMPLANTED TO STABILIZE THE CLIP 2. AFTER CLIP 3 WAS IMPLANTED, THE MR GRADE REMAINED AT 4. IT WAS CONFIRMED THAT THERE WAS NO DIFFICULTY WITH THE CLIPS OR WITH THE STEERING OF THE CLIPS. A JET REMAINS BETWEEN CLIP 1 AND CLIP 2; THEREFORE, IT IS POSSIBLE THAT A SECOND PROCEDURE WILL BE PERFORMED IN A FEW WEEKS TO IMPLANT A CLIP IN THIS AREA. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED DUE TO THE CLIP DETACHMENT; HOWEVER, THE PATIENT WAS CONFIRMED TO BE CLINICALLY STABLE POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333067 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10330785

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability