BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE

    MDR report key: 8973774 · Received September 9, 2019

    Report

    Report Number
    1220452-2019-00111
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K152335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA / 510(K) #: K152335 WAS NOT SUBMITTED IN THE ORIGINAL REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC CONDUCTED A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY TO COLLECT POSTMARKET INFORMATION ON THE SAFETY AND PERFORMANCE OF THE MEDTRONIC FAMILY OF ASPIRATION CATHETERS (EXPORT ADVANCE AND EXPORT AP). INTERVENTIONAL CARDIOLOGISTS WHO USE THE DEVICES PARTICIPATED IN THE SURVEY TO HELP CONFIRM USE OF THE DEVICES AND TO ENSURE MEDTRONIC IS AWARE OF ALL POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EXPORT ADVANCE AND EXPORT AP DEVICES. DURING USE OF THE EXPORT ADVANCE, ONE OCCURRENCE OF MYOCARDIAL INFARCTION WAS REPORTED TO BE RELATED TO A PRE-EXISTING CONDITION OR COMORBIDITY AND ONE OCCURRENCE OF EMBOLISM WAS REPORTED TO BE RELATED TO THE PROCEDURE BUT NOT DIRECTLY TO THE DEVICE. DURING USE OF THE EXPORT ADVANCE, CATHETER DEFORMATION WITH NO PROCEDURAL IMPACT OCCURRED IN ONE CASE. IT WAS STATED THAT THE PHYSICIAN'S STANDARD USE OF MEDTRONIC ASPIRATION CATHETERS DIFFERS FROM WHAT IS DESCRIBED IN THE IFU IN THAT THEY PERFORM SEVERAL ROTATIONS BACK AND FORTH. DURING USE OF THE EXPORT AP, MYOCARDIAL INFARCTION WAS REPORTED FOR ONE PATIENT AND EMBOLISM DIRECTLY RELATED TO THE DEVICE AS A RESULT OF THROMBUS FORMATION WAS REPORTED FOR ONE PATIENT. CATHETER DEFORMATION WITH NO PROCEDURAL IMPACT ALSO OCCURRED IN ONE CASE. IT WAS STATED THAT THE PHYSICIAN'S STANDARD USE OF MEDTRONIC ASPIRATION CATHETERS DIFFERS FROM WHAT IS DESCRIBED IN THE IFU IN THAT THEY LEAVE THE DEVICE IN ASPIRATION MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769949 ADVANCE CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1