BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3830573 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03304
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR THE 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). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE INCOMPLETE GRASPING OF BOTH LEAFLETS 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. IN THIS CASE, THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT THE POSTERIOR LEAFLET WAS PROLAPSED, AND THERE WAS NO FLAIL TO EITHER LEAFLET. AFTER DEPLOYMENT OF THE FIRST CLIP, A SECOND CDS WAS INSERTED AND THE LEAFLETS WERE GRASPED WITH EXCELLENT ECHOCARDIOGRAM IMAGING. LEAFLET INSERTION WAS ESTABLISHED WITHOUT DIFFICULTY, AND TWO GRASPS WERE MADE WITH NO ISSUES. AFTER SUCCESSFUL AND UNEVENTFUL DEPLOYMENT, IT WAS OBSERVED THAT THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET WITH NO DAMAGE OBSERVED, AND THE CLIP HAD REMAINED ATTACHED TO THE ANTERIOR LEAFLET. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS (PROLAPSED POSTERIOR LEAFLET) AND NOT A PRODUCT QUALITY DEFICIENCY. IT WAS FURTHER REPORTED THAT IMMEDIATELY FOLLOWING DEPLOYMENT OF THE SECOND CLIP, AND SLDA OF THE SECOND CLIP WAS OBSERVED, RESULTING IN THE INCREASE OF THE MR GRADE FROM TRACE (PRE-DEPLOYMENT) TO 2 (POST-DEPLOYMENT AND POST SLDA). THE PATIENT EFFECT OF WORSENING MR IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, 1 MITRACLIP IMPLANTED. 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 REPORT IS BEING FILED TO REPORT THAT THE MITRACLIP DETACHED FROM THE POSTERIOR LEAFLET DURING THE PROCEDURE, INCREASING THE MITRAL REGURGITATION. THIS IS CONSIDERED A SERIOUS INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE POSTERIOR LEAFLET WAS PROLAPSED. THERE WAS NO FLAIL OF EITHER LEAFLET. THE FIRST CLIP DELIVERY SYSTEM (CDS) WAS INSERTED AND ADVANCED PER THE INSTRUCTIONS FOR USE (IFU). THE CLIP WAS DEPLOYED AND THE MR WAS REDUCED TO 2. THE SECOND CDS (10290075/08) WAS ADVANCED AND THE LEAFLETS WERE GRASPED WITH EXCELLENT ECHOCARDIOGRAM IMAGING. LEAFLET INSERTION WAS ESTABLISHED WITHOUT DIFFICULTY. TWO GRASPING ATTEMPTS WERE NEEDED, AND THE CLIP WAS DEPLOYED PER THE IFU. THERE WAS NO ISSUE DURING PLACEMENT OR DEPLOYMENT OF THE CLIP, AND THE LEAFLET PATHOLOGY DID NOT CAUSE ANY CHALLENGES WITH GRASPING. THE MR WAS REDUCED TO TRACE. THE GRIPPER LINE WAS REMOVED WITHOUT DIFFICULTY. THE MR WAS ASSESSED AGAIN AND OBSERVED TO BE AT GRADE 2. FURTHER IMAGING SUGGESTED THAT THE POSTERIOR LEAFLET HAD DETACHED FROM THE 2ND CLIP, AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THERE WAS NO LEAFLET DAMAGE OBSERVED. NO FURTHER TREATMENT WAS PERFORMED. THE DECISION MADE TO WAIT AND SEE IF THE PATIENT BECOMES SYMPTOMATIC, AND THEN A FURTHER MITRACLIP INTERVENTION MAY BE CONSIDERED. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SUBSEQUENT TO THE INITIAL REPORT CONFIRMED THAT THE INCREASED MITRAL REGURGITATION WAS DUE TO THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308651 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10290075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R