BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOOSENECK SNARE

    MDR report key: 21916912 · Received April 28, 2025

    Report

    Report Number
    2183870-2025-00213
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    July 15, 2024
    Report Date
    April 28, 2025
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K970668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE PERCUTANEOUS REMOVAL OF CARDIAC PAPILLARY FIBROELASTOMAS JACC: CASE REPORTS VOL. 29, 2024 ª 2024 THE AUTHORS. PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FO UNDATION. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE ( HTTP://CREATIVECOMMONS.O RG/LICENSES/BY-NC-ND/4.0/ ) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AN 81-YEAR-OLD WOMAN WITH LUNG CANCER AND PREVIOUS CHEMORADIATION UNDERWENT A ROUTINE TTE WHICH REVEALED A 12- 10-MM AORTIC PFE (FIGURE 3A). GIVEN THE HIGH EMBOLIC RISK, SHE WAS REFERRED FOR PMA. AT THE TIME OF THE PROCEDURE, THE F18 ANGIOVAC (ANGIODYNAMICS) WAS AVAILABLE, AN ADDITIONAL DEVICE LONG ENOUGH FOR RETROAORTIC APPROACH. THE F18 ANGIOVAC SYSTEM PROVIDES CONTINUOUS FLOW ASPIRATION VIA AN EXTRACORPOREAL MEMBRANE OXYGENATION CIRCUIT THAT DRAWS BLOOD THROUGH A FILTER TO TRAP ASPIRATED SPECIMENS FOLLOWED BY BLOOD RETURN TO THE BODY VIA A SEPARATE ACCESS RETURN CANNULA. A 22-F SHEATH WAS USED FOR FEMORAL ACCESS WITH PRECLOSURE. AN 18-F RETURN CANNULA WAS PLACED IN THE FEMORAL VEIN. AFTER ESTABLISHING THE FLOW CIRCUIT, THE F18 ANGIOVAC CANNULA WAS ADVANCED TO THE ASCENDING AORTA AND CIRCUIT FLOW WAS INITIATED AT LOW SPEED (FIGURES 3C AND 3D). GIVEN THE RELATIVELY FIRM ADHESION OF THE PFE STALK, AN UPFRONT SNARE FROM A SEPARATE ARTERIAL ACCESS WAS INSERTED TO HELP CUT THE STALK WHILE CONCOMITANTLY ASPIRATING, SIMILAR TO A PREVIOUSLY DESCR IBED TECHNIQUE.3 THE ASPIRATION CATHETER WAS POSITIONED IN PROXIMITY TO THE PFE, AND CONTINUOUS ASPIRATION WAS INITIATED. THIS ALLOWED LOCKING THE MOBILITY OF THE PFE AND FACILITATED DEPLOYMENT OF THE 25-MM GOOSENECK SNARE (MEDTRONIC) AROUND ITS STALK, WHILE MITIGATING DISTAL EMBOLIZATION BY ASPIRATING POTENTIAL DEBRIS THAT MAY THEORETICALLY DISLODGE DURING MANIPULATION OF THE PFE (FIGURES 3E TO 3H). CIRCUIT SPEEDS WERE RAMPED UP, THE SNARE TIGHTENED TO CUT THE STALK, ALBEIT CHALLENGING TO VISUALIZE ON TRANSESOPHAGEAL ECH OCARDIOGRAPHY, AND THE PFE WAS SUCCESSFULLY ASPIRATED (FIGURES 3I AND 3J). THE SPECIMEN IN SALINE HAD TYPICAL SEA URCHIN-LIKE MORPHOLOGY CONSISTENT WITH PFE (FIGURES 3N AND 3O). POSTASPIRATION IMAGING REVEALED MODERATE TO SEVERE AORTIC REGURGITATION, CONFIRMED BOTH ON IMAGING AND HEMODYNAMICS, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE MECHANISM OF INJURY WAS LIKELY MECHANICAL FROM THE SNARE PULLING THE AORTIC LEAFLET TIP AND THE CHALLENGE WITH VISUAL IZING THE SNARE POSITION WITH RESPECT TO THE STALK OF THE PFE (FIGURES 3K AND 3L). GIVEN THE HEMODYNAMIC STABILITY, AND THE MODERATE TO SEVERE QUANTIFICATION, A DECISION WAS MADE TO DEFER TRANSCATHETER AORTIC VALVE REPLACEMENT. THERE WAS NO MATERIAL COLLECTED IN THE RETRIEVED CEREBRAL EMBOLIC PROTECTION DEVICE. HOWEVER, THE PATIENT NOTED WORSENING DYSPNEA ON EXERTION IN THE FOLLOWING WEEKS, AND UNDERWENT SUCCESSFUL TRANSCATHETER AORTIC VALVE REPLACEMENT USING AN OVERSIZED SELF-EXPANDING VALVE USING 26-MM EVOLUT FX (MEDTRONIC) IN THE SETTING OF PURE AORTIC REGURGITATION AND LACK OF CALCIUM (TRANSCATHETER AORTIC VALVE REPLACEMENT PLANNING PARAMETERS: AORTIC VALVE ANNULUS AREA: 320 MM2 , ANNULAR PERIMETER: 66 MM, SINOTUBULAR JUNCTION DIAMETER: 27 MM, SINOTUBULAR JUNCTION HEIGHT: 24 MM, SINUS OF VALSALVA DIAMETER 30 28 27 MM, LEFT CORONARY HEIGHT: 13 MM AND RIGHT CORONARY HEIGHT: 18 MM, AORTIC VALVE CALCIUM SCORE: 0) 4 WEEKS AFTER PMA (FIGURE 3M). PATHOLOGY CONFIRMED THE FINDING OF PFE (FIGURE 3P)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674962 GOOSENECK SNARE CATHETER, PERCUTANEOUS DQY COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention