BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOOSENECK SNARE

    MDR report key: 13085417 · Received December 24, 2021

    Report

    Report Number
    2183870-2021-00468
    Event Type
    Injury
    Date Received
    December 24, 2021
    Date of Event
    September 21, 2021
    Report Date
    February 2, 2022
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K970668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: DATE OF ARTICLE PUBLICATION (I.E. EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE) MIGRATION OF N-BCA GLUE AS A COMPLICATION OF VENOUS MALFORMATION TREATMENT IN CHILDREN RADIOLOGY CASE REPORTS (2021) 16(11):3526-3533 10.1016/J.RADCR.2021.07.065. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    A NON-MEDTRONIC PRODUCT WAS USED DURING THE PROCEDURE FOR GLUE EMBOLIZATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    THE ARTICLE DISCUSSES HOW PREOPERATIVE N-BUTYL CYANOACRYLATE (N-BCA) EMBOLIZATION OF VENOUS MALFORMATIONS FACILITATES SURGICAL RESECTION AND DESCRIBES A CASE OF GLUE MIGRATION REQUIRING GLUE EMBOLECTOMY. A (B)(6) MALE PRESENTED TO THE ORTHOPEDIC SURGERY CLINIC WITH SEVERAL MONTHS OF INTERMITTENT THROBBING AND DISCOMFORT IN THE RIGHT POSTERIOR THIGH. DIAGNOSTIC ULTRASOUND AND MRI DEMONSTRATED A 40 × 20 × 70 MM INTRAMUSCULAR LESION COMPATIBLE WITH A VENOUS MALFORMATION. GIVEN THE PATIENT¿S DISCOMFORT, HE WAS REFERRED FOR GLUE EMBOLIZATION AND EXCISION. IN THE IR SUITE, THE MALFORMATION WAS ACCESSED VIA STANDARD TECHNIQUE AND INITIAL VENOGRAPHY DEMONSTRATED A VASCULAR LESION WITH DRAINAGE INTO THE FEMORAL VEIN VIA DEEP PERFORATING VEINS; RAPID OUTFLOW WAS NOTED, SUGGESTING A POSSIBLE MIXED FAST-FLOW COMPONENT TO THE LESION. THE LESION WAS ACCESSED AT MULTIPLE LOCATIONS WITH INJECTION OF THE 1:4 N-BCA-ETHIODOL MIXTURE WITH SOME EGRESS INTO DRAINING VEINS. POSTEMBOLIZATION VENOGRAPHY SHOWED EGRESS OF GLUE INTO THE RIGHT FEMORAL VEIN WITH A STRING-LIKE EXTENSION TO THE RIGHT ILIAC VEIN. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL VEIN AT THE MID-THIGH, AND A 4FR SHEATH WAS PLACED. A GOOSENECK SNARE WAS THEN USED TO EXTRACT THE GLUE FRAGMENT, RESULTING IN FRAGMENT FRACTURE AND EMBOLIZATION OF SMALL GLUE FRAGMENTS INTO THE CENTRAL VENOUS CIRCULATION AND SUBSEQUENTLY INTO SUB-SEGMENTAL PULMONARY ARTERIES. CHEST IMAGING DEMONSTRATED SMALL SUB-SEGMENTAL RIGHT LOWER LOBE AND LEFT UPPER LOBE PULMONARY EMBOLI; THE EXTERNAL AND COMMON ILIAC VEINS WERE WIDELY PATENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR RESECTION OF THE MALFORMATION. HE REMAINED HEMODYNAMICALLY STABLE WITHOUT ADDITIONAL RESPIRATORY REQUIREMENTS AND WAS DISCHARGED HOME THE SAME DAY. BY PATIENT REPORT SEVERAL WEEKS LATER, HE WAS FEELING WELL WITHOUT ANY RESPIRATORY SYMPTOMS AND DID NOT RETURN FOR ADDITIONAL FOLLOW-UP. PATHOLOGY FROM THE LESION DEMONSTRATED BOTH VENOUS AND ARTERIAL COMPONENTS, SUGGESTIVE OF A MIXED MALFORMATION, PREDOMINANTLY VENOUS BUT WITH SOME HIGH FLOW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982529 GOOSENECK SNARE CATHETER, PERCUTANEOUS DQY COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention