BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17831051 · Received September 28, 2023

    Report

    Report Number
    2029214-2023-01883
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    March 20, 2023
    Report Date
    September 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. NO SPECIFIC DEVICE INFORMATION PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    CHEN, S. Q., LI, L., GAO, B. L., WU, Q. W., SHAO, Q. J., WANG, Z. L., ZHANG, K., LI, T. X. SAFETY AND EFFECT OF PIPELINE FEX EMBOLIZATION DEVICE FOR COMPLEX UNRUPTURED INTRACRANIAL ANEURYSMS. SCIENTIFIC REPORTS. 2023. 13:4570. DOI: 10.1038/S41598-023-31638-0 SUMMARY: TO INVESTIGATE THE SAFETY AND SHORT-TERM EFFECT OF PIPELINE FLEX DEVICES IN THE TREATMENT OF COMPLEX UNRUPTURED INTRACRANIAL ANEURYSMS, A RETROSPECTIVE STUDY WAS PERFORMED FOR PATIENTS WITH COMPLEX UNRUPTURED INTRACRANIAL ANEURYSMS WHO WERE TREATED WITH THE PIPELINE FLEX EMBOLIZATION DEVICE (PED FLEX DEVICE) COMBINED WITH OR WITHOUT COILING. THE CLINICAL, ENDOVASCULAR, AND FOLLOW-UP DATA WERE ANALYZED. ONE HUNDRED AND THIRTY-ONE PATIENTS WITH 159 COMPLEX UNRUPTURED CEREBRAL ANEURYSMS WERE TREATED WITH THE PED FLEX DEVICE, WITH 144 FLEX DEVICES DEPLOYED. PERIPROCEDURAL COMPLICATIONS OCCURRED IN FOUR PATIENTS, RESULTING IN THE COMPLICATION RATE OF 3.1%, INCLUDING ISCHEMIC COMPLICATIONS IN THREE PATIENTS (2.3%) AND HEMORRHAGIC COMPLICATION IN ONE (0.8%). AT DISCHARGE, THE MRS WAS 0 IN 101 (77.1%) PATIENTS, 1 IN 25 (19.1%), 2 IN FOUR (3.1%), AND 4 IN ONE (0.8%), WITH THE GOOD PROGNOSIS RATE (MRS 0¿2) OF 99.2%.CLINICAL FOLLOW-UP WAS CARRIED OUT IN 87 (66.4%) PATIENTS 3¿42 MONTHS AFTER THE PROCEDURE, WITH THE MRS OF 0 IN 78 (89.7%), 1 IN FVE (5.7%), 2 IN THREE (3.4%), AND 4 IN ONE (1.1%). NO SIGNIFICANT (P= 0.16) DIFFERENCE EXISTED IN THE MRS AT DISCHARGE COMPARED WITH THAT AT CLINICAL FOLLOW-UP. ANGIOGRAPHIC FOLLOW-UP WAS PERFORMED IN 61 (46.7%) PATIENTS WITH 80 (50.3%) ANEURYSMS AT 3¿40 MONTHS, WITH THE OKM GRADE OF D IN 57 (71.3%) ANEURYSMS, C IN EIGHT (10%), AND B IN 15 (18.8%). ASYMPTOMATIC INSTENT STENOSIS OCCURRED IN FOUR PATIENTS (6.6%). IN CONCLUSION: THE TREATMENT OF COMPLEX INTRACRANIAL ANEURYSMS WITH THE PIPELINE FLEX EMBOLIZATION DEVICE MAY BE SAFE AND EFFECTIVE, WITH A HIGH COMPLETE OCCLUSION RATE, A DECREASED COMPLICATION RATE, AND A GOOD PROGNOSIS RATE AT MEDIUM FOLLOW-UP. REPORTED EVENTS: IN ONE CASE WITH AN ANEURYSM AT THE POSTERIOR COMMUNICATING SEGMENT OF THE LEF INTERNAL CAROTID ARTERY, LIMB MOVEMENT DYSFUNCTION OCCURRED FOUR HOURS AFER EMBOLIZATION, WITH THE RIGHT LIMB MUSCLE STRENGTH OF GRADE 0. EMERGENCY DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED OCCLUSION OF THE PARENT ARTERY, AND MECHANICAL THROMBECTOMY WAS PERFORMED TO RESTORE THE PATENCY OF THE ARTERY, RESULTING IN AN MRS OF 1 AT DISCHARGE. 4. IN ONE CASE WITH AN ANEURYSM AT THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED SUDDEN HEADACHE THREE DAYS AFER EMBOLIZATION, COMPUTED TOMOGRAPHY DEMONSTRATED CEREBRAL HEMORRHAGE, MASS EFFECT, AND HERNIATION. AFER EMERGENCY CRANIOTOMY TO EVACUATE THE HEMATOMA, THE PATIENT WAS DISCHARGED WITH AN MRS OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341212 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention