BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 19816646 · Received July 24, 2024

    Report

    Report Number
    2184009-2024-00427
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K201057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D2: PRODUCT CODE UPDATED. CORRECTION D3: MANUFACTURER NAME AND ADDRESS UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    LITERATURE DETAILS: FABIAN SEEBER, NIKLAS KRENNER, EVA SAMES-DOLZER, ANDREAS TULZER, ISHITA SRIVASTAVA, MICHAELA KREUZER, ROLAND MAIR, GREGOR GIERLINGER, MOHAMMAD-PAIMANN NAWROZI, RUDOLF MAIR, OUTCOME AFTER EXTRACORPOREAL MEMBRANE OXYGENATION THERAPY IN NORWOOD PATIENTS BEFORE THE BI DIRECTIONAL GLENN OPERATION, EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, VOLUME 65, ISSUE 4, APRIL 2024, EZAE153, HTTPS://DOI.ORG/10.1093/EJCTS/EZAE153. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE OUTCOMES OF ECMO THERAPY IN PEDIATRIC PATIENTS UNDERGOING NORWOOD OPERATIONS, PARTICULARLY FOCUSING ON HEMODYNAMIC OR RESPIRATORY COMPLICATIONS POST-OPERATION. THE TIME FRAME OF THIS STUDY WAS: 2007 TO 2022, WITH FOLLOW-UP DATA AVAILABLE FOR A MEDIAN DURATION OF 4.8 YEARS AFTER DISCHARGE. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MEDTRONIC BIOMEDICUS CORTIVA COATED (8F) ARTERIAL CANNULAS (FOR NEONATES) MEDTRONIC BIOMEDICUS LIFE SUPPORT (9F) CANNULAS (IN THE AORTA) MEDTRONIC DLP CARMEDA COATED (16F, 18F) VENOUS CANNULAS. DEATHS OCCURRED IN THE STUDY POPULATION. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. THE CAUSES OF DEATH WERE: HOSPITAL MORTALITY POST-ECMO WEANING: 80% OF PATIENTS WITH TAPVC AND NORWOOD PROCEDURE (PAGE X), AND FONTAN FAILURE DURING FOLLOW-UP: 1 PATIENT (PAGE Y) AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SEPSIS, SEIZURES, CEREBRAL LESIONS, KIDNEY INJURY REQUIRING DIALYSIS. BLEEDING INSTANCES INVOLVED RETHORACOTOMY, INTRACEREBRAL BLEEDING, SUBDURAL HAEMATOMA AND DIFFUSE BOWEL BLEEDING. AMONG ALL PATIENTS, MALFUNCTIONS INCLUDED: INSUFFICIENT PERFUSION DURING VENOUS CANNULATION IN ONE PATIENT. IT WAS REPORTED THAT SWITCHING THE VENOUS CANNULA TO THE RIGHT ATRIUM WAS REQUIRED DUE TO INSUFFICIENT PERFUSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356284 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96010-009
    357937 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96010-009

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA Male Required Intervention| H