BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 4MM X 11.5CM

    MDR report key: 13010248 · Received December 15, 2021

    Report

    Report Number
    3008114965-2021-00671
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 13, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077817
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). SECTION B5: MODIFIED INFORMATION ON THE CLINICAL RESEARCH FORM (CRF) INDICATED THE FOLLOWING: ENDOVASCULAR INTERVENTION VALUE "NO" WAS CHANGED TO "YES". REMODELING BALLOON WAS POSITIONED AND INFLATED TO TREAT THE ANEURYSM PERFORATION. MEDICATION COMPLETE/UPDATE CONCOMITANT MEDICATIONS LOG VALUE "NO" WAS CHANGED TO "YES". PROTAMINE WAS ADMINISTERED TO REVERSE THE HEPARIN. DISCHARGE DATE VALUE. WAS CHANGED TO (B)(6) 2021. SECTION H6: HEALTH EFFECT - IMPACT CODE: MEDICATION REQUIRED. ADDITIONAL INFORMATION IS PENDING AS TO WHETHER THE PERFORATION WAS ASSOCIATED WITH THE TARGET ANEURYSM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PATIENT IDENTIFIER: (B)(6). THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE K10459 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2021-00670, 3008114965-2021-00672, AND 3008114965-2021-00673.

    Description of Event or Problem · 0

    AS REPORTED BY THE (B)(6) STUDY, A (B)(6) FEMALE ((B)(6)) WITH A HISTORY OF ACTIVE SMOKING AND INTRACRANIAL ANEURYSM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2021 AND EXPERIENCED INTRAOPERATIVE ANEURYSM PERFORATION. BALLOON OCCLUSION WAS PERFORMED AS INTERVENTION, AND THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT IS RECOVERING FROM THE EVENT. THE EVENT WAS CLASSIFIED AS SEVERE. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910012 MICRUSFRAME10 4MM X 11.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR100412 K10459 10886704077817

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization| R ECHELON 10 MICROCATHETER (MEDTRONIC)| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 2MM X 2CM| GALAXY G3 XSFT HEL 2MM X 6CM