BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR®

    MDR report key: 17217677 · Received June 28, 2023

    Report

    Report Number
    2021898-2023-00036
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    March 26, 2023
    Report Date
    June 28, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. 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.

    Description of Event or Problem · 0

    SANGARA, R.N., CHON, A.H., VAN SPEYBROECK, A.L., CHU, J.K., LLANES, A.S., KONTOPOULOS, E.V., QUINTERO, R.A., CHMAIT, R.H. FETAL BLOOD GASES AFTER IN UTERO CARBON DIOXIDE INSUFFLATION FOR PERCUTANEOUS FETOSCOPIC SPINA BIFIDA REPAIR. JOURNAL OF OBSTETRICS GYNECOLOGY. 2021. 3 (100409) DOI: 10.1016/J.AJOGMF.2021.100409 ABSTRACT BACKGROUND: PRENATAL REPAIR OF OPEN SPINA BIFIDA VIA THE PERCUTANEOUS FETOSCOPIC APPROACH DOES NOT REQUIRE MATERNAL LAPAROTOMY, HYSTEROTOMY, OR EXTERIORIZATION OF THE UTERUS. THIS TECHNIQUE REQUIRES INTRAUTERINE PARTIAL CO2 INSUFFLATION. LIMITED DATA EXIST ON THE PHYSIOLOGICAL EFFECTS OF CO2 INSUFFLATION ON HUMAN FETUSES, WITH NO DATA ON OPEN SPINA BIFIDA REPAIR PERFORMED USING THE ENTIRELY PERCUTANEOUS FETOSCOPIC SURGICAL TECHNIQUE. OBJECTIVE: OUR AIM WAS TO EXAMINE THE EFFECTS OF INTRAUTERINE PARTIAL CO2 INSUFFLATION ON FETAL BLOOD GASES AFTER PERCUTANEOUS FETOSCOPIC OPEN SPINA BIFIDA REPAIR. STUDY DESIGN: THIS WAS A PROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT PERCUTANEOUS FETOSCOPIC OPEN SPINA BIFIDA REPAIR FROM FEBRUARY 2019 TO JULY 2020. FETAL CORDOCENTESIS OF THE UMBILICAL VEIN WAS PERFORMED IN CASES WITH FAVORABLE ACCESS TO THE UMBILICAL CORD. THE UMBILICAL VEIN CORD BLOOD SAMPLES WERE OBTAINED UNDER ULTRASOUND GUIDANCE IMMEDIATELY AT THE CONCLUSION OF THE OPEN SPINA BIFIDA REPAIR. SIMULTANEOUS MATERNAL ARTERIAL BLOOD GAS SAMPLES WERE ALSO OBTAINED. THE RESULTS ARE REPORTED AS MEDIAN (RANGE). RESULTS: OF THE 20 PATIENTS WHO UNDERWENT PERCUTANEOUS FETOSCOPIC OPEN SPINA BIFIDA REPAIR DURING THE STUDY PERIOD, 7 PATIENTS (35%) UNDERWENT FETAL BLOOD SAMPLING. THE GESTATIONAL AGE AT THE TIME OF SURGERY WAS 27.4 (24.0-27.9) WEEKS AND THE OPERATIVE TIME WAS 183 (156-251) MINUTES. THE CO2 EXPOSURE TIME WAS 122 (57-146) MINUTES WITH MAXIMUM PRESSURE OF 13.5 (12.0-15.0) MM HG. FETAL UMBILICAL VEIN RESULTS WERE AS FOLLOWS: PH 7.35 (7.30-7.39), PARTIAL PRESSURE OF O2 56.2 (47.1-99.9) MM HG, PARTIAL PRESSURE OF CO2 43.8 (36.2-53.0) MM HG, HCO3 23.9 (20.1-25.6) MMOL/L, AND BASE EXCESS -2.2 (-4.5 TO -0.4) MMOL/L. SIMULTANEOUS MATERNAL ARTERIAL BLOOD GAS RESULTS WERE AS FOLLOWS: PH 7.37 (7.28-7.42), PARTIAL PRESSURE OF O2 187.5 (124.4-405.2) MM HG, PARTIAL PRESSURE OF CO2 36.6 (30.7-46.0) MM HG, HCO3 21.3 (18.0-22.8) MMOL/L AND BASE EXCESS -3.2 (-5.9 TO -1.8) MMOL/L. CONCLUSION: DESPITE PROLONGED CO2INSUFFLATION OF THE UTERUS, FETAL UMBILICAL VEIN PH AND BASE EXCESS VALUES DID NOT APPROACH THOSE A SSOCIATED WITH POTENTIALLY PATHOLOGIC FETAL ACIDEMIA. REPORTABLE EVENTS: 2 (28.6%) CASES HAD BRIEF EPISODES OF FETAL BRADY­CARDIA DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725024 DUREPAIR® DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention