BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 4111000 · Received September 23, 2014

    Report

    Report Number
    2025587-2014-00690
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 6, 2014
    Report Date
    February 26, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CARDIOVASCULAR INJURIES INCLUDING DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EFFECTS, PER COREVALVE INSTRUCTIONS FOR USE (IFU) THAT CAN OCCUR DURING ANY INVASIVE PROCEDURE AND DO NOT INDICATE A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. IT WAS REPORTED BY THE SITE THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THAT REMOVAL OF THE SHEATH WAS COMPLICATED BY DISSECTION OF THE RIGHT EXTERNAL ILIAC/COMMON FEMORAL ARTERY, THE PHYSICIAN NOTED THAT THIS MAY BE RELATED TO THE DELIVERY CATHETER SYSTEM DEVICE. THE PATIENT REQUIRED A BALLOON ANGIOPLASTY AND ADJUNCTIVE STENTING. NORMAL ANTEGRADE FLOW WAS RESTORED TO THE RIGHT LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591501 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0007068081

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention