BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PICCOLO

    MDR report key: 17770243 · Received September 18, 2023

    Report

    Report Number
    2135147-2023-04055
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    August 5, 2022
    Report Date
    October 11, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    UDI-DI
    05415067031044
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE EMBOLIZATION AFTER IMPLANT WAS REPORTED. ORIGINAL DEPLOYMENT HAD IMMEDIATE EMBOLIZATION OF THIS DEVICE THAT WAS CONFIRMED IN FLUOROSCOPY. THE EMBOLIZED DEVICE WAS SUCCESSFULLY RETRIEVED VIAGOOSENECK SNARE, OUT OF THE PATIENT. 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. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. NA.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 05 AUGUST 2022, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8421938) WAS CHOSEN FOR IMPLANT, USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM FOR 30 DAYS OLD, 1.2 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DIAMETER OF 3.5MM, LENGTH OF 11.3MM, AND DIAMETER AT AORTIC AMPULLA OF 4.5MM. IT WAS INDICATED THAT THE PHYSICIAN FELT MEASUREMENTS AND WEIGHT WERE "BORDERLINE" BETWEEN DEVICE CHOICES. PER PHYSICIAN DOWNSIZING WAS NOT AN OPTION. ORIGINAL DEPLOYMENT HAD IMMEDIATE EMBOLIZATION OF THIS DEVICE THAT WAS CONFIRMED IN FLUOROSCOPY, WHICH WAS RETRIEVED VIA 10MM GOOSENECK SNARE, AND REMOVED FROM THE PATIENT. A REPLACEMENT 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8160390) WAS SUCCESSFULLY IMPLANTED WITH SATISFACTORY RESULT PER PHYSICIAN. ON (B)(6)2022, ECHOCARDIOGRAM SHOWED OBSTRUCTION ON THE LEFT PULMONARY ARTERY (LPA) DUE TO PATIENT ANATOMY. THE PATIENT EXPERIENCED DIFFICULTY BREATHING, REQUIRING RESPIRATORY SUPPORT. THE PATIENT UNDERWENT MEDICAL INTERVENTION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS INTO THE LPA. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL LPA ANGIOPLASTY. THE PATIENT WAS DISCHARGED AND REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143625 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL 8421938 05415067031044

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Male Required Intervention AMPLATZER TORQVUE LP DS, 9-TVLP4F90/060