BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 9741494 · Received February 21, 2020

    Report

    Report Number
    2182208-2020-00344
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 1, 2019
    Report Date
    February 21, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿ARTERIOVENOUS FEMORAL FISTULA AFTER INSERTION OF LEADLESS PACEMAKER¿A CASE WITH AN ANOMALY OF THE DEEP FEMORAL ARTERY.¿ JOURNAL OF ARRHYTHMIA. 2019; 35(5):770-772. 10.1002/JOA3.12224. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THE INTRODUCER SHEATH FOR THE LEADLESS PACEMAKER. THE AUTHOR INDICATED THAT THERE WAS ONE (1) PATIENT WHO EXPERIENCED AN ARTERIOVENOUS FISTULA (AVF). AFTER REMOVAL OF THE VENOUS SHEATH, ARTERIAL BLEEDING WAS OBSERVED, WHICH STOPPED AFTER THREE HOURS OF MANUAL COMPRESSION. THE PHYSICIAN INDICATED THAT THERE ¿SHUNT SOUNDS¿ WERE OBSERVED AND AN AVF WAS DIAGNOSED VIA SONOGRAPHY. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO IDENTIFY THE ETIOLOGY OF THE AVF WHICH REVEALED THAT THE PATIENT¿S RIGHT DEEP FEMORAL ARTERY (DFA) WAS ¿ARISING FROM THE ANTERO-MEDIAL SIDE OF THE MAIN FEMORAL ARTERY.¿ THE PHYSICIAN STATED THAT THIS HAD ¿ATTRIBUTED TO THIS COMPLICATION.¿ THE PATIENT DID HAVE MILD PAIN AND A HEMATOMA AT THE PUNCTURE SITE. THERE WAS ALSO AN INCREASE IN BRAIN NATRIURETIC PEPTIDE (BNP) DUE TO THE FISTULA. HOWEVER, SINCE THERE WERE NO OTHER SYMPTOMS, THE PHYSICIAN OPTED NOT TO PERFORM ANY SURGICAL INTERVENTION. DURING THE FOLLOW UP PERIOD OF SIX MONTHS, THE PATIENT DID NOT COMPLAIN OF ANY SYMPTOMS. THE STATUS /LOCATION OF THE INTRODUCER IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201921 MICRA INTRODUCER, CATHETER DYB MEDTRONIC, INC. MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening