BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM

    MDR report key: 15459304 · Received September 20, 2022

    Report

    Report Number
    2135147-2022-01279
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 22, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010304
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER (LOT: 6303607) WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE RIGHT ATRIAL DISC OF THE DEVICE WOULD NOT LAY FLAT WHEN DEPLOYED AND PLACED INTO A SMALL IATROGENIC ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER (LOT: 7548234). DURING DEPLOYMENT, THE RIGHT ATRIAL DISC WOULD NOT LAY FLAT AND WAS REMOVED FROM THE PATIENT. THE DEVICE WAS EXCHANGED WITH ANOTHER UNKNOWN SIZED AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS A DELAY IN PROCEDURE DUE TO THE TWO DEVICE EXCHANGES, BUT NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT HAS SINCE BEEN DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER (LOT: 6303607) WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE RIGHT ATRIAL DISC OF THE DEVICE WOULD NOT LAY FLAT WHEN DEPLOYED AND PLACED INTO A SMALL IATROGENIC ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER (LOT: 7548234). DURING DEPLOYMENT, THE RIGHT ATRIAL DISC WOULD NOT LAY FLAT AND WAS REMOVED FROM THE PATIENT. THE DEVICE WAS EXCHANGED WITH ANOTHER UNKNOWN SIZED AMPLATZER MULTI-FENESTRATED SEPTAL CRIBRIFORM OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS A DELAY IN PROCEDURE DUE TO THE TWO DEVICE EXCHANGES, BUT NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT HAS SINCE BEEN DISCHARGED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DELIVERY SYSTEM USED IS OF UNKNOWN MANUFACTURER. THE DELIVERY SYSTEM WAS ALSO REPLACED WITH AN UNKNOWN DELIVERY SYSTEM. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126975 AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL MF SEPTAL OCCLUDER CRIBRIFORM 7548234 00811806010304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown