BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3884970 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03960
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE 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/DIFFICULTY GRASPING CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE/PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS) OR MANUFACTURING ANOMALIES. POTENTIAL CAUSES FOR THE CLIP BECOMING CAUGHT ON THE CHORDAE RESULTING IN DIFFICULTY REMOVING THE DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE AND PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO VISUALIZE THE DEVICE IN RELATION TO THE MITRAL VALVE) OR MANUFACTURING ANOMALIES. BASED ON THE INFORMATION REVIEWED, THE REPORTED CLIP CAUGHT IN CHORDAE/DIFFICULTY REMOVING THE CDS APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS AND NOT A PRODUCT DEFICIENCY ASSOCIATED WITH THIS DEVICE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY GRASPING THE LEAFLETS MAY BE INFLUENCED BY 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. BASED ON THE INFORMATION REVIEWED, THE REPORTED FAILURE TO ADHERE OR BOND TO THE LEAFLETS/DIFFICULTY GRASPING APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS, AS THE REPORTED DIFFICULTY WAS LIKELY DUE TO A COMBINATION OF THE CHALLENGING ANATOMY AND WORSENING OF THE COAPTATION DUE TO FLUID MANAGEMENT. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE. THE PATIENT EFFECTS OF WORSENING MR AND MITRAL VALVE INJURY (TISSUE DAMAGE), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. IN THIS CASE, THE MOST PROBABLE CAUSE FOR THE WORSENING MR WAS DUE TO A COMBINATION OF THE INABILITY TO GRASP THE LEAFLETS AND CHORDAL RUPTURE. ALTHOUGH A DEFINITIVE CAUSE FOR THE CHORDAL RUPTURE/TISSUE DAMAGE AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, 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 ISSUED TO THE REPORTED LOT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: PRECAUTION WAS TAKEN WHILE RETRACTING THE CDS WITH THE CLIP IN INVERTED ARM ANGLE POSITION FROM LV (LEFT VENTRICLE) TO LA (LEFT ATRIUM). SOME RESISTANCE WAS FELT, AND IT IS BELIEVED THAT THE CLIP BECAME CAUGHT ON THE CHORDAE. THE PHYSICIAN DOES NOT BELIEVE THAT THE CLIP CONTRIBUTED TO THE RESISTANCE WITH THE CHORDAE. IMMEDIATELY AFTER THE SYSTEM WAS REMOVED, IT WAS OBSERVED THAT A CHORDAE RUPTURE OCCURRED ON THE A2 LEAFLET, AND THE MR GRADE HAD INCREASED TO 4. THE PATIENT WAS CLINICALLY STABLE BUT WAS HOSPITALIZED LONGER THAN EXPECTED FOR OBSERVATION. NO FURTHER TREATMENT HAS BEEN PLANNED. ACCORDING TO THE EVALUATION OF THE TREATING PHYSICIAN, IT IS SUSPECTED THAT THE SMALL CHORD RUPTURE MIGHT HAVE CONTRIBUTED TO THE INABILITY TO GRASP BOTH OF THE LEAFLETS. ADDITIONALLY, THE PROLONGED PROCEDURE TIME, RESULTING IN A WORSENING OF THE COAPTATION DUE TO FLUID MANAGEMENT DURING THE PROCEDURE, MIGHT HAVE ALSO CONTRIBUTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THE MITRACLIP WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THE RESISTANCE WITH THE CHORDAE DURING REMOVAL OF THE CLIP DELIVERY SYSTEM (CDS 10314895/03) WHICH RESULTED IN A CHORDAE RUPTURE AND INCREASED MITRAL REGURGITATION WHICH IS CONSIDERED SERIOUS INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATIONAL (MR) WITH A GRADE OF 3. THE PATIENT HAD MILD TO MODERATE LEFT VENTRICLE FUNCTION WITH A CENTRAL JET. DURING EVALUATION OF THE PATIENT FOR THE PROCEDURE, ECHO CONFIRMED NO ABNORMALITIES. THE TRANS-SEPTAL PUNCTURE WAS PERFORMED PER STANDARD PROCEDURE. THE CDS (10314895/03) WAS INSERTED INTO THE STEERABLE GUIDING CATHETER (SGC) AND THE MITRACLIP SYSTEM WAS ADVANCED WITHOUT ANY ISSUES. SEVERAL ATTEMPTS WERE MADE TO GRASP BOTH LEAFLETS, WHICH RESULTED IN ONE SUCCESSFUL GRASP, BUT THERE WAS ONLY MILD REDUCTION IN MR. THE DECISION WAS MADE TO OPEN THE CLIP AND TRY FOR ANOTHER GRASP WITH A MORE SUCCESSFUL REDUCTION IN MR. NUMEROUS ATTEMPTS TO GRASP BOTH LEAFLETS WERE MADE WITHOUT LOWERING THE GRIPPERS. THE CLIP WAS REPOSITIONED TO LATERAL AND MEDIAL, AND THE ANGLE OF THE CLIP WAS CORRECTED BY ADDING PLUS AND MINUS, BUT THE LEAFLETS COULD NOT BE GRASPED. AFTER OVER 2 HOURS OF ATTEMPTING TO GRASP THE LEAFLETS, IT WAS DECIDED TO ABORT THE PROCEDURE. THERE WERE NO DIFFICULTIES NOTED WITH VISUALIZATION OF THE CLIP, AND NO UNEXPECTED MOVEMENTS OR STEERING. IT WAS CONFIRMED THAT THERE WAS NO EVIDENCE OF A DEVICE ISSUE RESULTING IN THE INABILITY TO GRASP LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362041 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10314895

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization MITRACLIP SYSTEM STEERABLE GUIDE CATHETER