BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3768557 · Received April 23, 2014

    Report

    Report Number
    2024168-2014-02543
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, MITRACLIP (X1). THE MITACLIP IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST MITRACLIP CDS NUMBER REFERENCED IS CORRECTED FROM 1031495/01 TO 10314915/01. EVALUATION SUMMARY: THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED PRODUCT WERE REVIEWED. DURING DEVICE TESTING, NO ISSUES WERE IDENTIFIED WITH THE REMOVABILITY TEST WITH AND WITHOUT CURVES ON THE CLIP DELIVERY SYSTEM (CDS). AS THE STEERABLE GUIDE CATHETER (SGC) ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED WITH THE DEVICE, A PROXY SGC WAS USED TO TEST GRIPPER LINE REMOVABILITY IN WATER BATH. THE CDS AND SGC WERE INSERTED INTO A WATER BATH, AND 75 DEGREE SGC / 90 DEGREE CDS CURVES WERE APPLIED TO THE SYSTEM. THE REPORTED UNABLE TO REMOVE GRIPPER LINE WAS CONFIRMED DURING WATER BATH TESTING WITH THESE CURVES APPLIED. THE DEVICE WAS REINSERTED INTO THE SGC, AND THE MITRACLIP SYSTEM WAS SUBMITTED FOR X-RAY ANALYSIS. THE ANALYSIS OF THE SYSTEM AND THE DC SHAFT DID NOT IDENTIFY ANY HERNIATION IN THE LUMEN COILS THAT WOULD HAVE CONTRIBUTED TO THE INABILITY TO REMOVE THE GRIPPER LINE DURING THE PROCEDURE. FOLLOWING X-RAY ANALYSIS, THE CDS WAS REMOVED FROM THE SGC, AND THE GRIPPER LINE WAS REMOVED. NO DAMAGE OR KINKS WERE OBSERVED ON THE GRIPPER LINE. ADDITIONALLY, A SNARE WAS USED TO TEST EACH GRIPPER LUMEN, AND NO DIFFICULTIES OR RESISTANCE WAS NOTED DURING SNARE TESTING. AS THE REPORTED DIFFICULT TO REMOVE CLIP FROM THE CHORDAE WAS RELATED TO PROCEDURAL CONDITIONS, THE REPORTED EVENT COULD NOT BE TESTED. POTENTIAL CAUSES FOR THE UNABLE TO REMOVE GRIPPER LINE 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 REMOVE THE GRIPPER LINE). ADDITIONALLY, POTENTIAL CAUSES FOR THE DIFFICULT TO REMOVE / CLIP CAUGHT ON CHORDAE 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 VISUALIZE THE CLIP IN RELATION TO THE MITRAL VALVE). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE INABILITY TO REMOVE THE GRIPPER LINE MAY BE INFLUENCED BY THE CURVATURE OF THE DEVICE WITH RESPECT TO THE PATIENT ANATOMY, TWISTS / KNOTS ON THE GRIPPER LINE, KINKS / DAMAGES TO THE GRIPPER LINE, OR HERNIATION IN THE LUMEN COILS AS A RESULT OF HANDLING. BASED ON THE INFORMATION REVIEWED, WHILE A DEFINITIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE DIFFICULT TO REMOVE GRIPPER LINE RESULTED FROM PROCEDURAL INTERACTIONS, COUPLED WITH THE CURVATURE OF THE STEERABLE SLEEVE SHAFT WHILE POSITIONING THE CLIP; DUE TO THIS CURVING, IT IS POSSIBLE THAT THE LUMENS BECAME SHIFTED, RESULTING IN CONSTRICTIVE FORCES ON THE GRIPPER LINE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE DIFFICULT TO REMOVE CLIP FROM CHORDAE / CHORDAE RUPTURE MAY BE INFLUENCED BY THE MORPHOLOGY OF THE MITRAL VALVE, DIFFICULTIES VISUALIZING THE CLIP DURING PLACEMENT, EXCESSIVE FORCE OR RANGE OF ROTATION / TRANSLATION WHILE MANIPULATING THE DEVICE, INABILITY TO INVERT THE CLIP PRIOR TO RETRACTING IT THROUGH THE VALVE, OR THE CLIP BEING UNABLE TO OPEN OR UNLOCK AFTER BECOMING ENTANGLED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED CLIP BEING CAUGHT ON THE CHORDAE COULD NOT BE DETERMINED. THE PATIENT EFFECTS OF TISSUE DAMAGE (MITRAL VALVE INJURY) AND WORSENING MITRAL REGURGITATION ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. IN THIS CASE, THE REPORTED CHORDAL RUPTURE WAS LIKELY A RESULT OF THE CLIP GETTING CAUGHT IN THE CHORDAE, AND IN THE INCREASED MR WAS LIKELY DUE TO THE CHORDAL RUPTURE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE MANUFACTURING, 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THERE WERE NO STEERING ISSUES NOTED WITH THE SECOND CLIP DELIVERY SYSTEM (CDS). IN THE OPINION OF THE PHYSICIAN, THE DEVICE ENTANGLEMENT IN CHORDAE WAS NOT A RESULT OF A DEVICE STEERING ISSUE. IT WAS REPORTED THAT IF THE GRIPPER LINE HAD BEEN REMOVABLE, THE CLIP WOULD NOT HAVE BEEN OPENED, AND THE CDS WOULD NOT HAVE BEEN ENTANGLED IN THE CHORDAE. THE ENTANGLEMENT WAS NOT A RESULT OF CLIP LOCATION (TOO LATERAL / MEDIAL). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS FILED FOR THE CLIP DELIVERY SYSTEM (CDS 1031495/(B)(4)) WHICH EXPERIENCED DIFFICULTY DURING REMOVAL OF THE GRIPPER LINE. ADDITIONALLY, DURING REMOVAL OF THE CDS, THE CLIP BECAME CAUGHT ON THE CHORDAE RESULTING IN CHORDAL RUPTURE AND REQUIRED MEDICAL INTERVENTION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4, WITH A PROLAPSED POSTERIOR LEAFLET. THE FIRST CLIP (1031495/(B)(4)) WAS IMPLANTED AND THE MR GRADE WAS REDUCED TO 2-3. THE SECOND CLIP WAS THEN POSITIONED LATERAL TO THE FIRST CLIP. PRIOR TO DEPLOYMENT OF THE CLIP, THE MR GRADE WAS BETWEEN 2-1 AND >1. THE CLIP WAS DEPLOYED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). BOTH CAPS AND POLYMERS WERE REMOVED. IT WAS CONFIRMED THAT NO TWISTS OR KNOTS WERE PRESENT IN THE GRIPPER LINE, BUT THE GRIPPER LINE COULD NOT BE MOVED IN EITHER DIRECTION, EVEN AFTER OPENING THE CLIP. THE LOCK LINE WAS FIXED AND THE CLIP WAS OPENED AND PULLED BACK INTO THE LEFT ATRIUM. DURING REMOVAL, THE CLIP BECAME CAUGHT ON THE CHORDAE, AND A CHORDAL RUPTURE OCCURRED. THE MR GRADE INCREASED TO 3. THE CDS AND CLIP WERE REMOVED SUCCESSFULLY. A NEW CLIP (10293185/(B)(4)) WAS THEN DEPLOYED LATERAL TO THE FIRST CLIP AND THE MR WAS REDUCED TO 2. A THIRD CLIP (10312475/(B)(4)) WAS THEN IMPLANTED LATERAL TO THE SECOND CLIP, FOR TREATMENT OF THE INCREASED MR, AND THE MR WAS REDUCED TO TRACE. THERE WAS NO EVIDENCE OF CHORDAL RUPTURE PRIOR TO THE PROCEDURE. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247404 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10317975

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention