BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASCULAR PLUG

    MDR report key: 12437919 · Received September 8, 2021

    Report

    Report Number
    3007170829-2021-00018
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    April 29, 2021
    Report Date
    November 11, 2021
    Manufacturer
    REVERSE MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K150108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE GENDER BREAKDOWN OF PATIENTS WERE AN EVEN MIX. THE DEVICE MIGRATED DISTALLY IN SEVERAL PATIENTS. THE AUTHOR HAS STATED THAT THIS IS NOT VIEWED AS A DEVICE "MALFUNCTION", BUT RATHER A USE OF DEVICE FOR THIS SITUATION NOT BEING ADEQUATE. 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.

    Additional Manufacturer Narrative · 1

    TITLE: TOTAL TRANSCATHETER STAGE: A WORD OF CAUTION AUTHOR: STEPHEN NAGEOTTE, SHABANA SHAHANAVAZ, PIROOZ EGHTESADY JOURNAL: PEDIATRIC CARDIOLOGY YEAR: 2021. VOL/ISSUE: 42. REF: (B)(4). AVERAGE AGE. MAJORITY GENDER. DATE OF PUBLICATION JOURNAL REPORTED DEATH BUT THERE IS NO INFORMATION TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. REPORT SOURCE: PMA/5109(K) MVP 5Q (K141313) AND MVP 7Q (K150108) USED ALSO USED DURING PROCEDURES: UNKNOWN WHICH SIZE PATIENT RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED REVIEWING A CASE SERIES OF 6 PATIENTS WHO UNDERWENT A PERCUTANEOUS MODIFIED STAGE 1 APPROACH USING MODIFIED MICROVASCULAR PLUGS (MVP). THE INITIAL PROCEDURE WAS TECHNICALLY SUCCESSFUL WITH SINGLE-STAGE DUCTAL STENTING AND PLACEMENT OF BILATERAL MODIFIED MVP VIA FEMORAL ACCESS. PATIENT CASE REPORT DETAILS WERE INCLUDED FOR A PATIENT WITH SHONE¿S COMPLEX, MULTIPLE VSDS, HYPOPLASTIC AORTIC ARCH WITH SEPSIS. FINAL ANGIOGRAPHY DEMONSTRATED THAT THE RPA DEVICE MIGRATED DISTALLY AFTER RELEASED AND CROSSED THE UPPER LOBE TAKEOFF. AN ARCH REPAIR WITH REMOVAL OF MVPS AND DUCTAL STENT WAS PERFORMED 2 WEEKS POST INTERVENTION WITH THE MVP DEVICE. PATIENT IS REPORTED TO BE DOING WEEK 16 MONTHS POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337615 MICROVASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD REVERSE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention