BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASCULAR PLUG

    MDR report key: 13903941 · Received March 25, 2022

    Report

    Report Number
    3007170829-2022-00003
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    January 28, 2022
    Report Date
    June 20, 2022
    Manufacturer
    REVERSE MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K141313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: EMBOLIZATION OF VASCULAR ABNORMALITIES IN CHILDREN WITH CONGENITAL HEART DISEASES USING MEDTRONIC MICRO VASCULAR PLUGS AUTHOR: RAYMOND N. HADDAD, DAMIEN BONNET, SOPHIE MALEKZADEH-MILANI JOURNAL: HEART AND VESSELS YEAR: 2022 REF: 10.1007/S00380-021-02007-6. AGE: AVERAGE AGE, GENDER: MAJORITY GENDER, EVENT DATE: DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. 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

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A STUDY EVALUATING EXPERIENCE WITH MICRO VASCULAR PLUG (MVP) FOR EMBOLIZATION OF VASCULAR ABNORMALITIES IN CHILDREN WITH CONGENITAL HEART DISEASES (CHDS). 153 PATIENTS UNDERWENT 172 PROCEDURES DURING WHICH 240 EMBOLIZATIONS USING 259 MVPS WERE ATTEMPTED. TARGET VESSELS WERE AORTOPULMONARY COLLATERALS (APCS) (N=100), PULMONARY SEQUESTRATION ARTERIAL VESSEL SUPPLIES (N=25), ARTERIAL DUCTS (N=26), INTERNAL MAMMARY ARTERIES SUPPLYING COLLATERAL ARTERIES TO THE LUNG (N=22), VENOVENOUS FISTULAE (N=24), VENO-CARDIAC FISTULAE (N=16), CORONARY FISTULAE (N=6), BLALOCK-TAUSSIG SHUNTS (N=5), LEFT SUPERIOR CAVAL VEIN (N=4), AZYGOS VEIN (N=1), AND OTHER VESSELS¿ MALFORMATIONS (N=11). ALL IMPLANTED MVPS WERE UNEVENTFULLY DETACHED FROM THE FIRST ATTEMPT. IN 30.8% OF CASES, MULTIPLE MVPS WERE IMPLANTED DURING THE SAME INTERVENTION. THE MOST COMMONLY USED DEVICE WAS MVP-5Q. THE MVP-9Q WAS USED IN ONLY 3 PATIENTS. TWO MVPS WERE USED IN 14 PATIENTS TO ENSURE COMPLETE CLOSURE. OVERALL PROCEDURE SUCCESS RATE WAS 99.2%. 252 MVPS WERE PLACED SUCCESSFULLY AND IN SEVEN PATIENTS THE DEVICE HAD TO BE RETRIEVED BEFORE RELEASE. FOLLOWING DEVICE PLACEMENT, IMMEDIATE ANGIOGRAPHIC EVALUATION SHOWED RESIDUAL SHUNTING IN 21.1% OF CASES BUT THIS RATE IMMEDIATELY DROPPED TO 5.5% BY ADDING COILS OR OTHER OCCLUDER DEVICES. IN ONE PATIENT WITH AORTOPULMONARY COLLATERAL, THE MVP PROTRUDED IN THE AORTA AND HAD TO BE DOWNGRADED IN SIZE FOR OPTIMAL CLOSURE. IN THE REMAINING 6 PATIENTS, THE DEVICE WAS UNSTABLE WITH SIGNIFICANT RESIDUAL SHUNT LEADING TO MVP SIZE UPGRADE (N=3), SWITCH TO ANOTHER OCCLUDER DEVICE (N=2), AND PROCEDURE ABORTION (N=1). ALL TRIVIAL SHUNTS DISAPPEARED BEFORE DISCHARGE. MODERATE SHUNTS WERE PERCUTANEOUSLY TREATED USING ANOTHER MVP (N=2) OR WERE COMPLICATED WITH DEVICE EMBOLIZATION/MIGRATION (N=5). OVERALL, THERE WERE 4 DEVICE EMBOLIZATIONS AND 4 MIGRATIONS. TWO DEVICES EMBOLIZED IMMEDIATELY AFTER RELEASE AND TWO DEVICES (MVP-5Q AND MVP-7Q) EMBOLIZED INTO THE PULMONARY ARTERIES 24 H AFTER ARTERIAL DUCT CLOSURES. ALL THESE 4 DEVICES WERE PERCUTANEOUSLY RETRIEVED. THE TWO ARTERIAL DUCTS WERE CLOSED WITH AN MVP-7Q AND A DUCT OCCLUDER, RESPECTIVELY. DEVICE MIGRATIONS WERE IMMEDIATELY DETECTED AFTER RELEASE WITHOUT SEQUELAE (N=2) AND ACROSS FOLLOW-UP (N=2). ONE MVP-5Q MOBILIZED TO A LARGER PART OF A CORONARY FISTULA AND WAS TREATED BY ADDING ANOTHER ADJACENT MVP-5Q FOR STABILITY AND COMPLETE SHUNT CLOSURE. ANOTHER MVP-5Q MIGRATED DISTALLY IN A PULMONARY SEQUESTRATION ARTERIAL VESSEL SUPPLY WHERE IT STABILIZED WITH COMPLETE SHUNT CLOSURE. ONE AORTIC COARCTATION WAS SECONDARY TO MVP-5Q PROTRUSION. IT WAS DETECTED 2 MONTHS FOLLOWING ARTERIAL DUCT CLOSURE AND THE DEVICE HAD TO BE SURGICALLY RECAPTURED AFTER FAILED PERCUTANEOUS RECAPTURE. IN ANOTHER PATIENT WITH TYPE III PULMONARY ATRESIA-VENTRICULAR SEPTAL DEFECT, ROUTINE DIAGNOSTIC CT-SCAN PERFORMED AFTER 4 YEARS FORTUITOUSLY REVEALED DISTAL MIGRATION OF AN MVP-5Q INITIALLY DEPLOYED IN AN APC INTO THE LEFT INFERIOR LOBE PULMONARY ARTERY WITH NO SEQUELAE. THERE WAS NO HEMOLYSIS, OR ANY OTHER VASCULAR OR DEVICE RELATED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009409 MICROVASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD REVERSE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Male Required Intervention