BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3864190 · Received June 10, 2014

    Report

    Report Number
    2024168-2014-03710
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLIP DELIVERY SYSTEM (CDS) WAS REPORTED TO HAVE BEEN DISCARDED. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CDS. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE), EMBOLISM AND THROMBOSIS, AND INTRACRANIAL HEMORRHAGE (BLEEDING), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NONCONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: PRIOR TO THE MITRACLIP PROCEDURE, THE PATIENT WAS ON COUMADIN FOR ATRIAL FIBRILLATION AND POST PROCEDURE THE COUMADIN WAS RESUMED. THE PARTIAL THROMBOPLASTIN TIME (PTT) WAS 100. TWO DAYS POST PROCEDURE, (B)(6) 2014, THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE WITH LEFT NEGLECT, FACIAL DROOPING AND RIGHT GAZE PREFERENCE. THE PATIENT HAD A VENTRICULOSTOMY AND WAS ADMINISTERED VITAMIN K AND PLATELETS. A CEREBRAL ANGIOGRAM AND MULTIPLE MAGNETIC RESONANCE IMAGING TESTS (MRI) WERE PERFORMED. THE PHYSICIANS HAVE NOT FOUND THE SOURCE OF THE HEMORRHAGE. IN THE ABSENCE OF A SOURCE, THE PHYSICIANS ASSIGNED THE CAUSE TO A HEMORRHAGIC CONVERSION OF EMBOLI. THE PATIENT WAS IN THE NEURO INTENSIVE CARE UNIT AND WAS STABLE. THE PATIENT CONDITION HAD IMPROVED WITH TREATMENT. THE PATIENT IS NOW FOLLOWING SIMPLE COMMANDS AND CAN TRACK EYES PAST THE MIDLINE AND IS MOVING HIS RIGHT UPPER EXTREMITY AND MOVING BILATERAL LOWER. HE CAN MOVE LEFT SIDE WITH VERBAL CUES, BUT NOT SPONTANEOUSLY. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: LIFT, SUPPORT PLATE, STABILIZER, STEERABLE GUIDE CATHETER. THE CUSTOMER REPORTED THE DEVICE 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 BEING FILED AS THROMBUS WAS OBSERVED AT THE CLIP AND POST PROCEDURE, THE PATIENT HAD A STROKE. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN OPTIMAL LOCATION WITHOUT INCIDENT. THE PATIENT WAS ADMINISTERED HEPARIN. THE STEERABLE GUIDE CATHETER (SGC) WAS PREPPED FOR USE. THE ACTIVATED CLOTTING TIME WAS MEASURED TO BE ABOVE 250 AND THE SGC WAS INTRODUCED INTO THE ANATOMY WITHOUT INCIDENT. THE CLIP DELIVERY SYSTEM (CDS) WAS PREPPED WITH HEPARINIZED SALINE WITHOUT INCIDENT AND INTRODUCED INTO THE ANATOMY. DURING STEERING IN THE LEFT ATRIUM, AS CLIP PERPENDICULARITY WAS ALMOST ACHIEVED, A THROMBUS WAS NOTED AT THE TIP OF THE CLIP. THE CURVES OF THE DEVICE WERE CAREFULLY REMOVED FROM THE CDS AND THE CLIP WAS RETRACTED BACK INTO THE SGC AND REMOVED FROM THE PATIENT. ONCE OUTSIDE OF THE ANATOMY, THE THROMBUS WAS NOTED ON THE CLIP. THE SGC WAS ASPIRATED AND CONFIRMED TO BE FREE OF THE THROMBUS AND THEN FLUSHED. HEPARIN INDUCED THROMBOCYTOPENIA WAS NOT SUSPECTED. ANOTHER CDS WAS PREPPED FOR USE AND WAS INTRODUCED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF ONE CLIP REDUCING THE DEGENERATIVE MITRAL REGURGITATION GRADE FROM 4 TO LESS THAN 1. THE PATIENT WAS EXTUBATED ON THE TABLE. POST PROCEDURE, THE PATIENT WAS CLINICALLY STABLE AND WAS FEELING VERY GOOD. THE PATIENT WAS ADMINISTERED 325MG OF ASPIRIN PER STANDARD TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338098 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10304875

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S