BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHENOM

    MDR report key: 21540789 · Received March 6, 2025

    Report

    Report Number
    2029214-2025-00580
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    April 3, 2024
    Report Date
    March 6, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: GOERTZ, L., HOHENSTATT, S., VOLLHERBST, D. F., WEYLAND, C. S., NIKOUBASHMAN, O., STYCZEN, H., GRONEMANN, C., WEISS, D., KASCHNER, M., PFLAEGING, M., SIEBERT, E., ZOPFS, D., KOTTLORS, J., PENNIG, L., S. SAFETY AND EFFICACY OF COATED FLOW DIVERTERS IN THE TREATMENT OF RUPTURED INTRACRANIAL ANEURYSMS: A RETROSPECTIVE MULTICENTER STUDY.. JOURNAL OF NEUROINTERVENTIONAL SURGERY 17(3), 304¿310 2025. DOI:10.1136/JNIS-2024-021516 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

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF MINOR STROKE WITH THE PATIENT DEVELOPING HEMIHYPESTHESIA, DISSECTION OF THE VERTEBRAL ARTERY, IN-STENT THROMBOSIS DURING THE PROCEDURE, THROMBOEMBOLIC OCCLUSION, ANAPHYLACTIC REACTION TO CONTRAST, AND RESIDUAL/REMNANT ANEURYSMS IN ASSOCIATION WITH FLOW DIVERSION EMBOLIZATION INVOLVING USE OF PHENOM CATHETERS 21 AND/OR 27, REBAR CATHETERS 18 AND/OR 27, PIPELINE VANTAGE, AND PIPELINE FLEX WITH SHIELD TECHNOLOGY. THE TIME FRAME OF THIS STUDY WAS BETWEEN FEBRUARY 2016 AND SEPTEMBER 2023. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF COATED FLOW DIVERTERS (CFDS) FOR THE TREATMENT OF RUPTURED INTRACRANIAL ANEURYSMS. THE AUTHORS REVIEWED 60 CASES OF PATIENTS TREATED FOR ANEURYSMS USING FLOW DIVERSION UTILIZING THE PIPELINE VANTAGE OR PIPELINE FLEX WITH SHIELD TECHNOLOGY, PHENOM 21 CATHETER, PHENOM 27 CATHETER, AND/OR REBAR 18 CATHETER, AND REBAR 27 CATHETER. OF THE 60 PATIENTS, THE AVERAGE AGE WAS 55 YEARS, 32 WERE FEMALE AND 28 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PHENOM 21 CATHETER, PHENOM 27 CATHETER, REBAR 18 CATHETER, REBAR 27 CATHETER, PIPELINE VANTAGE FLOW DIVERTER, AND PIPELINE FLEX WITH SHIELD TECHNOLOGY FLOW DIVERTER. AT DISCHARGE 40 PATIENTS HAD A GOOD OUTCOME (MRS SCORE OF 0-2). THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: STROKE LEADING TO DEATH IN 1 PATIENT TREATED WITH A PIPELINE SHIELD CAUSED BY DUAL ANTIPLATELET TREATMENT BEING MISSED POSTOPERATIVELY 9 DEATHS WERE REPORTED TO BE CAUSED BY THE SUBARACHNOID HEMORRHAGE AND WERE NOT TREATMENT RELATED 2 MINOR STROKES (1 PATIENT TREATED WITH PIPELINE VANTAGE AND THE OTHER PATIENT TREATED WITH FRED X STENT) 1 PATIENT DEVELOPED HEMIHYPESTHESIA (PIPELINE VANTAGE) 1 PATIENT DEVELOPED MILD HEMIPARESIS (FRED X) DISSECTION OF THE VERTEBRAL ARTERY DURING TREATMENT OF A BASILAR TIP ANEURYSM WITH A P48 HPC STENT WHICH WAS TREATED CONSERVATIVELY (MEDTRONIC CATHETER USE CANNOT BE RULED OUT). PROCEDURAL IN-STENT THROMBOSIS DURING TREATMENT OF A MYCOTIC BASILAR TRUNK ANEURYSM WITH FRED X. THROMBUS DISSOLVED WITH INTRA-ARTERIAL TIROFIBAN AND ASPIRATION THROMBECTOMY (MEDTRONIC CATHETER USE CANNOT BE RULED OUT) THROMBOEMBOLIC A2 OCCLUSION DURING TREATMENT WITH P64 HPC STENT. MECHANICAL THROMBECTOMY COMPLETED WITH NO HEMORRHAGIC COMPLICATIONS. (MEDTRONIC CATHETER USE CANNOT BE RULED OUT). 1 ANAPHYLACTIC REACTION TO CONTRAST 3 PATIENTS HAD REMNANT ANEURYSMS AND 4 PATIENTS HAD RESIDUAL FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437921 PHENOM CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening SEE H11...