BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASCULAR PLUG

    MDR report key: 16643009 · Received March 30, 2023

    Report

    Report Number
    2183870-2023-00099
    Event Type
    Injury
    Date Received
    March 30, 2023
    Report Date
    June 9, 2023
    Manufacturer
    COVIDIEN
    Product Code
    KRD
    PMA / PMN Number
    K141313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE REINTERVENTION FOR GELFOAM EMBOLISATION WITHIN THE SPLEEN FOR INTRASENIC HEMORRHAGE AND MIGRATION OF THE MVP IN THE HILUM OF THE SPLEEN ACHIEVED SPLENIC INFARCTION OCCURRED 30 DAYS FROM INDEX PROCEDURE. 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.

    Additional Manufacturer Narrative · 0

    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. 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

    MEDTRONIC CONDUCTED A POST MARKET CLINICAL AGGREGATED DATA COLLECTION SURVEY TO EVALUATE THE SAFETY AND PERFORMANCE OF MVP¿ MICRO VASCULAR PLUG SYSTEM. THE PURPOSE OF THIS CLINICAL AGGREGATED DATA COLLECTION SURVEY WAS TO COLLECT RETROSPECTIVE AGGREGATED PATIENT DATA FROM CLINICIAN CUSTOMERS WHO USE THE MEDTRONIC MVP¿ MICRO VASCULAR PLUG SYSTEM. DATA INCLUDES EXISTING CLINICAL DATA IN THE SITE¿S MEDICAL RECORDS FROM PATIENTS THAT HAVE BEEN TREATED WITH THE MVP¿ MICRO VASCULAR PLUG SYSTEM. VESSELS TREATED INCLUDED THE SPLENIC ARTERY, RENAL ARTERY, GASTRODUODENAL ARTERY, LUMBAR ARTERIES, INTERNAL ILIAC ARTERY, UPPER RIG HT EXTREMITIES AND UPPER LEFT EXTREMITIES. MVP MIGRATION WAS REPORTED. ONE PATIENT EXPERIENCED GELFOAM EMBOLISATION WITHIN THE SPLEEN FOR INTRASPLENIC HEMORRHAGE AND MIGRATION OF THE MVP IN THE HILUM OF THE SPLEEN RESULTING IN SPLENIC INFARCTION. THE REINTERVENTION AT THE SITE WAS A SPLENECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172655 MICROVASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention