BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3832555 · Received May 27, 2014

    Report

    Report Number
    2025587-2014-00324
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    January 16, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT WAS NOT RETURNED, THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: THE IFU STATES: ¿CONTINUE TO TURN THE MICRO KNOB UNTIL BOTH FRAME LOOPS DISENGAGE. USE ORTHOGONAL VIEWS UNDER FLUOROSCOPY TO CONFIRM THAT THE FRAME LOOPS HAVE DETACHED FROM THE CATHETER TABS. IF A FRAME LOOP IS STILL ATTACHED TO A CATHETER TAB, UNDER FLUOROSCOPY, ADVANCE THE CATHETER SLIGHTLY AND, IF NECESSARY, GENTLY ROTATE THE HANDLE CLOCKWISE (<(><<)>180°) AND COUNTERCLOCKWISE (<(><<)>180°) TO DISENGAGE THE LOOP FROM THE CATHETER TAB.¿ IT WAS REPORTED THAT THE USER CORRECTLY FOLLOWED THIS TECHNIQUE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS THE PROCEDURAL FILM SUBMITTED FOR REVIEW. THEREFORE, FURTHER IDENTIFICATION OF CONTRIBUTING FACTORS COULD NOT BE EVALUATED NOR CAN A CONCLUSIVE CAUSE BE DETERMINED. PROCEDURAL FILMS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED AND SHOWED THAT THE DELIVERY CATHETER SYSTEM (DCS) MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE CINEANGIOGRAPHIC IMAGES THAT WERE PROVIDED DID NOT DOCUMENT THE VALVE IMPLANT. THE FIRST CINE SERIES SHOWED THE VALVE ALREADY IMPLANTED IN THE ASCENDING AORTA AND THEN DOCUMENTED IMPLANT OF THE REPLACEMENT VALVE. THE DCS WAS NOT RETURNED FOR ANALYSIS. FROM THE AVAILABLE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED ENTANGLEMENT AND SUBSEQUENT DIFFICULTY WITH VALVE RELEASE CANNOT BE DETERMINED. A FRAME LOOP ENTANGLEMENT CAN OCCUR BASED ON THE ORIENTATION OF THE VALVE FRAME LOOPS/ DCS TABS TO THE PATIENT ANATOMY, OR BASED ON THE ANGLE OF DEPLOYMENT BETWEEN THE VALVE FRAME AND THE DCS. THE INSTRUCTIONS FOR USE PROVIDES THE INSTRUCTION TO ENSURE BOTH FRAME LOOPS HAVE RELEASED PRIOR TO REMOVING THE DCS, AS WELL AS TECHNIQUES TO RELEASE A FRAME LOOP IF ONE REMAINS ATTACHED. IT IS UNKNOWN AND CANNOT BE CONFIRMED WITHOUT A CINE RECORD WHETHER THE PROPER TECHNIQUE WAS FOLLOWED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS DIFFICULTY RELEASING THE FRAME HOOKS FROM THE DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS PULLED OUT OF THE ANNULUS AND RELEASED IN THE ASCENDING AORTA. A NON-MEDTRONIC VALVE WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS REPORTED. IT WAS REPORTED THAT THE PRESCRIBED RELEASE MANEUVERS DESCRIBED IN THE IFU WERE PERFORMED. THE CUSTOMER DISCARDED THE PRODUCT. THE PROCEDURAL FILMS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311733 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0006907162

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention