BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM

    MDR report key: 20414495 · Received October 10, 2024

    Report

    Report Number
    2029214-2024-01825
    Event Type
    Death
    Date Received
    October 10, 2024
    Date of Event
    December 1, 2023
    Report Date
    October 10, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SAB (LOT: UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-SAB (LOT: UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-AXIUM (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A, PRODUCT ID UNK-NV-PED2 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A. G2: CITATION: AUTHORS: DUANGPRASERT, G., NOIPHITHAK, R., SUKHOR, S., & TANTONGTIP, D.. EFFICACY AND PREDICTING FACTORS OF MULTIMODAL TREATMENT FOR RUPTURED INTRACRANIAL VERTEBRAL ARTERY DISSECTING ANEURYSMS. NEUROSURGICAL REVIEW 46(1) 2023. DOI:10.1007/S1014 3-023-02226-7. 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 'EFFICACY AND PREDICTING FACTORS OF MULTIMODAL TREATMENT FOR RUPTURED INTRACRANIAL VERTEBRAL ARTERY DISSECTING ANEURYSMS' (PAGE 1). THE TIME FRAME OF THIS STUDY WAS 'MARCH 2015 TO MAY 2022' (PAGE 2). MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION (PAGE 1). THE FOLLOWING MEDTRONIC DEVICES WERE USED: FLOW DIVERSION DEVICE (FDD) PIPELINE FLEX WITH SHIELD TECHNOLOGY (11 PATIENTS) O THERE WERE NO ISCHEMIC OR HEMORRHAGIC COMPLICATIONS THAT OCCURRED AFTER THE FDD IMPLANTATION. COIL TRAPPING WAS PERFORMED USING AXIUM COILS (17 PATIENTS). STENT-ASSISTED COILING (SAC) USED A SOLITAIRE AB OR NON-MEDTRONIC STENT (3 PATIENTS) DEATHS OCCURRED IN THE STUDY POPULATION (PAGE 5). THERE WERE 3 CASES OF MORTALITY. THE CAUSES OF DEATH WERE: SEVERE SUBARACHNOID HEMORRHAGE LEADING TO BRAIN DEATH (1 DEATH) (PAGE 5). ONE OF THREE SAC CASES HAD COMPLICATIONS WITH SEVERE INTRAOPERATIVE RUPTURE AND REBLEED DUE TO MICROCATHETER PERFORATION INTO THE FALSE LUMEN, NECESSITATING AN EMERGENCY SUBOCCIPITAL CRANIECTOMY WITH CLIPPING. HOWEVER, THE PATIENT DIED 3 DAYS AFTER THE PROCEDURE DUE TO THE CONSEQUENCE OF SEVERE SUBARACHNOID HEMORRHAGE (SAH) WHICH LED TO BRAIN DEATH. ANEURYSM RE-RUPTURE FOLLOWED BY A FATAL MYOCARDIAL INFARCTION (1 DEATH) (PAGE 5). ANOTHER SAC PATIENT EXPERIENCED AN ANEURYSM RE-RUPTURE DESPITE COMPLETE ANEURYSM OBLITERATION SHOWN ON FOLLOW-UP CTA AT 12 MONTHS POST-OPERATION. THIS PATIENT HAD A SMALL ANEURYSM RECURRENCE OF 2 MM IN SIZE AT 24 MONTHS. HOWEVER, THE PATIENT DECLINED FURTHER TREATMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANEURYSM RE-RUPTURE AT 34 MONTHS, WHICH WAS FOLLOWED BY A FATAL MYOCARDIAL INFARCTION BEFORE ANY FURTHER TREATMENT COULD BE ADMINISTERED. POSTOPERATIVE VERTEBROBASILAR ISCHEMIA (VBI) LEADING TO BRAIN DEATH. THE PATIENT SUFFERED FROM A SEVERE BRAINSTEM INFARCTION AFTER COIL TRAPPING OF THE AFFECTED VERTEBRAL ARTERY (VA), WHICH CONSEQUENTLY LED TO BRAIN DEATH. THE PATIENT HAD DEVELOPED MODERATE RIGHT HEMIPARESIS AND CONFUSION 6 HOURS AFTER SURGERY. MRI REVEALED AN EARLY INFARCTION OF THE LEFT PONS, WHICH WAS PRESUMED TO BE CAUSED BY OCCLUSION OF THE PERFORATORS OF THE COIL MASS. UNFORTUNATELY, A FEW HOURS LATER, DESPITE THE HYPERTENSIVE THERAPY, THE CLINICAL CONDITION DETERIORATED TO COMATOSE WITH NO BRAINSTEM REFLEXES. AMONG PATIENT ADVERSE EVENTS INCLUDED: POSTOPERATIVE VERTEBROBASILAR ISCHEMIA (VBI) (5 CASES IN THE DECONSTRUCTION GROUP) (PAGE 4, 6). THERE WERE 4 PATIENTS IN THE COIL TRAPPING TREATMENT GROUP WHO DEVELOPED VBI WHERE THE EVENTS OCCURRED EARLY IN THE FIRST 24 HOURS FOLLOWING THE PROCEDURES. TWO PATIENTS HAD INFARCTION OF THE LATERAL PONS/MEDULLA AND POSTERIOR CEREBRAL ARTERY TERRITORIES AND UNDERWENT THE SUPERFICIAL TEMPORAL ARTERY-POSTERIOR CEREBRAL ARTERY BYPASS TO AUGMENT THE BLOOD FLOW TO THE VERTEBROBASILAR CIRCULATION. ONE PATIENT HAD SEVERE CEREBRAL VASOSPASM IN THE CONTRALATERAL VA, WHICH IMPROVED AFTER INTRAARTERIAL VASODILATOR INJECTION AND ANGIOPLASTY. THESE 3 CASES HAD UNFAVORABLE OUTCOMES AND THE MRS WAS EVALUATED AT 4 DURING FOLLOW-UP. THE OTHER LED TO BRAIN DEATH AS NOTED ABOVE. RECURRENCE OCCURRED IN 1 CASE OF THE COIL TRAPPING GROUP, WHICH WAS DISCOVERED FROM FOLLOW-UP ANGIOGRAPHY AT 4 MONTHS. THE PATIENT EVENTUALLY UNDERWENT A SECOND ENDOVASCULAR TREATMENT USING COIL TRAPPING TO OBLITERATE THE ANEURYSM. PERIPROCEDURAL HYDROCEPHALUS OCCURRED IN 13 TOTAL PATIENTS. SEVERE CEREBRAL VASOSPASM (1 CASE). TRIPLE-H THERAPY WAS USED TO TREAT CLINICAL CEREBRAL VASOSPASM, AND ENDOVASCULAR TREATMENT (INTRAARTERIAL VASODILATOR INJECTION AND/OR ANGIOPLASTY) WAS PERFORMED IN REFRACTORY CASES OR IN PATIENTS WITH SEVERE CEREBRAL VASOSPASM. (PAGE 7). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947081 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-AXIUM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death SEE H11...