BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 19194104 · Received April 26, 2024

    Report

    Report Number
    2029214-2024-00773
    Event Type
    Death
    Date Received
    April 26, 2024
    Date of Event
    December 16, 2020
    Report Date
    April 26, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NV UNK PIPELINE (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A; PRODUCT ID UNK-NV-FG (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: JOHNSON, R. M., YOUNG, M., GUGLIELMI, G. N., & FARHAT, H.. PROXIMAL BASILAR ARTERY HEMORRHAGE AFTER SUBMAXIMAL ANGIOPLASTY FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE PRESENTING AS A LARGE VESSEL OCCLUSION TREATED WITH PIPELINE EMBOLIZATION DEVICE. JOURNAL OF CEREBROVASCULAR & ENDOVASCULAR NEUROSURGERY 2 2021. DOI:10.7461/JCEN.2021.E2020.11.005 DATE OF ACCEPTANCE 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

    JOHNSON RM, YOUNG M, GUGLIELMI GN, FARHAT H. PROXIMAL BASILAR ARTERY HEMORRHAGE AFTER SUBMAXIMAL ANGIOPLASTY FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE PRESENTING AS A LARGE VESSEL OCCLUSION TREATED WITH PIPELINE EMBOLIZATION DEVICE. JOURNAL OF CEREBROVASCULAR & ENDOVASCULAR NEUROSURGERY. 2021;23(2):145-151. DOI:10.7461/JCEN.2021.E2020.11.005 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF HEMORRHAGE AND DEATH IN ASSOCIATION WITH PHENOM27 MICROCATHETER AND PIPELINE STENTS. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT A UNIQUE CASE OF AN IATROGENIC PROXIMAL BASILAR ARTERY PERFORATION AFTER SUBMAXIMAL ANGIOPLASTY IN A 67-YEAR-OLD MALE PRESENTING WITH AN ACUTE BASILAR ARTERY OCCLUSION WITH UNDERLYING INTRACRANIAL ATHEROSCLEROTIC DISEASE. TELESCOPING FLOW-DIVERTING STENTS WERE THEN DEPLOYED TO RECONSTRUCT THE VESSEL WALL WITH RESULTING ACTIVE HEMORRHAGE RESOLUTION. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINES OR PHENOM. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -POST-PROCEDURE HEAD CT CONFIRMED DIFFUSE SUBARACHNOID HEMORRHAGE WITH INTRAVENTRICULAR HEMORRHAGE. THE PATIENT¿S NEUROLOGIC EXAMINATION CONTINUED TO DETERIORATE WITH GRADUAL LOSS OF BRAINSTEM REFLEXES. THE PATIENT DIED ON POST-PROCEDURE DAY TWO AFTER FAMILY DECISION TO TRANSITION TO COMFORT CARE MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039083 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death SEE H11...