BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19634142 · Received June 28, 2024

    Report

    Report Number
    2135147-2024-03131
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    March 31, 2022
    Report Date
    July 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. A2: MEAN AGE A3: MAJORITY GENDER B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6A: DATE OF IMPLANT WAS ESTIMATED. ARTICLE TITLE " IMPACT OF LEFT ATRIAL PRESSURE ON OUTCOMES AFTER MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR".

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART/LOT INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE AND THE ARTICLE COVERING MULTIPLE PATIENTS, A CAUSE FOR THE REPORTED MITRAL VALVE INSUFFICIENCY/REGURGITATION (MR), MITRAL STENOSIS, HEART FAILURE/CONGESTIVE HEART FAILURE AND DEATH CANNOT BE DETERMINED. HOWEVER, HEART FAILURE, MITRAL REGURGITATION, MITRAL STENOSIS AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A2: MEAN AGE. A3: MAJORITY GENDER. B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. D6A: DATE OF IMPLANT WAS ESTIMATED. LITERATURE ATTACHMENT: ARTICLE TITLE: IMPACT OF LEFT ATRIAL PRESSURE ON OUTCOMES AFTER MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR.

    Description of Event or Problem · 0

    THE ARTICLE "IMPACT OF LEFT ATRIAL PRESSURE ON OUTCOMES AFTER MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF INCREASED LEFT ATRIAL PRESSURE (LAP) MEASURED AT THE CONCLUSION OF MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER), WITH PARTICULAR ATTENTION TO DIFFERENCES AMONG PATIENTS WITH PRIMARY OR SECONDARY MITRAL REGURGITATION (MR), AND TO ASSESS THE EFFECT OF BASELINE LAP ON OUTCOMES. DEVICES MENTIONED INCLUDE THE MITRACLIP AND STEERABLE GUIDE CATHETER. THIS STUDY CONCLUDED THAT ELEVATED LAP AFTER M-TEER WAS ASSOCIATED WITH INCREASED 2-YEAR RISK OF MORTALITY OR HEART FAILURE HOSPITALIZATION. EXPLORATION OF REASONS FOR ELEVATED LAP AFTER M-TEER, AND WAYS TO LOWER IT WARRANT FURTHER INVESTIGATION. THE PRIMARY AUTHORS ARE YASSER M. SAMMOUR, MD, MSC, AND RODY G. BOU CHAAYA, MD. HOUSTON METHODIST DEBAKEY HEART AND VASCULAR CENTER, HOUSTON, TEXAS. THE CORRESPONDING AUTHOR IS: SACHIN S. GOEL, MD, HOUSTON METHODIST DEBAKEY HEART AND VASCULAR CENTER, ASSISTANT PROFESSOR, WEIL CORNELL MEDICAL COLLEGE, 6550 FANNIN STREET, SMITH TOWER, SUITE-18.53, HOUSTON, TX 77030, TEL: 216-773-1388, FAX: 713-790-2643, AND E-MAIL: [email protected]. THE TIME FRAME OF THE STUDY WAS MARCH 2014 TO MARCH 2022. ALL PROCEDURES WERE AT (B)(6) HOSPITAL. A TOTAL OF 273 PATIENTS WERE INCLUDED IN THIS STUDY, ALL OF WHICH RECEIVED A MITRACLIP DEVICE. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 78. THE MAJORITY GENDER WAS MALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED: DEGENERATIVE MITRAL REGURGITATION, FUNCTIONAL MITRAL REGURGITATION, MIXED MITRAL REGURGITATION, TRICUSPID REGURGITATION, MITRAL ANNULAR CALCIFICATION (MAC), PRIOR SURGICAL RING, HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI), PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), PRIOR MYOCARDIAL INFARCTION, PRIOR STROKE, ATRIAL FIBRILLATION / FLUTTER, PRIOR PACEMAKER OR INTRACARDIAC CARDIOVERTER DEFIBRILLATOR (ICD), CHRONIC KIDNEY DISEASE STAGE, DIALYSIS, AND HEART FAILURE. (B)(4): COMPLICATIONS INCLUDED: ALL-CAUSE MORTALITY AT 2 YEARS, HEART FAILURE HOSPITALIZATION AT 2 YEARS, MITRAL REGURGITATION, AND MITRAL STENOSIS. (B)(4): USING THE MITRACLIP 24F STEERABLE GUIDE CATHETER, BASELINE LAP WAS MEASURED DIRECTLY AFTER TRANSSEPTAL PUNCTURE, WHEREAS POST-TEER LAP WAS REPORTED AFTER FINAL CLIP DEPLOYMENT AND WITHDRAWAL OF THE CLIP DELIVERY SYSTEM. THE ARTICLE STATED THAT, "CONTINUOUS (LAP) MONITORING USING THE STEERABLE GUIDE CATHETER CAN BE DONE, HOWEVER THIS MAY BE LESS ACCURATE IN OUR EXPERIENCE AS THE CLIP DELIVERY SYSTEM IS MANEUVERED THROUGH THE GUIDE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816090 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization