BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3

    MDR report key: 22749961 · Received August 8, 2025

    Report

    Report Number
    3011468686-2025-00074
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    January 16, 2025
    Report Date
    August 8, 2025
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 70413 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A; PRODUCT ID 70415 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A; PRODUCT ID 70413 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 70415 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A; PRODUCT ID 70413 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A; CITATION: MICHAEL SOBOLIC, YUJIN PARK, SHARADA H. GOWDA. EARLY USE EXPERIENCE OF THE CRESCENT RIGHT ATRIAL CANNULA FOR NEONATAL VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION. ASAIO JAN 16 2025. 10.1097/MAT.0000000000002371, EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: EARLY USE EXPERIENCE OF THE CRESCENT RIGHT ATRIAL CANNULA FOR NEONATAL VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION. THE TIME FRAME OF THIS STUDY WAS: SEPTEMBER 2021 THROUGH AUGUST 2023. THE FOLLOWING MEDTRONIC DEVICES WERE USED: THE CRESCENT RIGHT ATRIAL (RA) CANNULA. THE MAJORITY OF PATIENTS WERE CANNULATED WITH THE 13 FR CANNULA, HOWEVER THE 15 FR CANNULA WAS ALSO USED. THERE WERE NO IMMEDIATE COMPLICATIONS DURING CANNULATION. DEATHS OCCURRED IN THE STUDY POPULATION. BASED ON THE AVAILABLE INFORMATION, THESE DEATHS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. THE CAUSES OF DEATH WERE: PERFORATION OF THE INFERIOR VENA CAVA (IVC) (LEADING TO HEMOPERICARDIUM, CARDIAC ARREST), DISSEMINATED HERPES SIMPLEX VIRUS (HSV), SARS-COV-2, NEONATAL RESPIRATORY DISTRESS SYNDROME, SEPTIC SHOCK, AND PULMONARY HEMORRHAGE. AMONG PATIENT ADVERSE EVENTS INCLUDED: PERFORATION, CANNULA MALPOSITION, REQUIRING SURGICAL REPOSITIONING, AND CLINICALLY SIGNIFICANT RECIRCULATION. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, DEVICE MALFUNCTIONS INCLUDED: FLOW ISSUES (DEFINED AS SUBOPTIMAL ECMO FLOW), CANNULA MALPOSITION. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENTS WERE RELATED DIRECTLY TO THE MEDTRONIC DEVICES. THERE WAS A CARDIAC PERFORATION AT THE RA/IVC JUNCTION, DUE TO THE 13 FR CRESCENT RA CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250204 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70415

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Unknown