BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17735945 · Received September 13, 2023

    Report

    Report Number
    2029214-2023-01680
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    October 18, 2022
    Report Date
    September 13, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: HAN, M., TONG, X., WANG, Z., & LIU, A. PARENT ARTERY OCCLUSION AFTER PIPELINE EMBOLIZATION DEVICE IMPLANTATION OF INTRACRANIAL SACCULAR AND FUSIFORM ANEURYSMS. JOURNAL OF NEUROINTERVENTIONAL SURGERY 2022. DOI:10.1136/JNIS-2022-019273. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HAN M, TONG X, WANG Z, LIU A. PARENT ARTERY OCCLUSION AFTER PIPELINE EMBOLIZATION DEVICE IMPLANTATION OF INTRACRANIAL SACCULAR AND FUSIFORM ANEURYSMS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. NOVEMBER 2022. DOI:10.1136/JNIS-2022-019273. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE INCIDENCE RATE AND RISK FACTORS OF PARENT ARTERY OCCLUSION (PAO) AFTER PIPELINE EMBOLIZATION DEVICE (PED) IMPLANTATION. FROM JANUARY 2012 TO DECEMBER 2020, 709 PATIENTS WITH 862 SACCULAR AND FUSIFORM INTRACRANIAL ANEURYSMS (IAS) WERE TREATED WITH PED IMPLANTATION. AMONG THESE IAS, 588 (68.2%) IAS HAD POSTOPERATIVE IMAGING DATA AVAILABLE AND WERE FINALLY ENROLLED IN THIS STUDY. A TOTAL OF 436 (74.1%) PATIENTS WERE WOMEN AND MEAN AGE WAS 53.5 YEARS. THE USE OF PED ALONE OR WITH ASSISTED COILING, MULTIPLE PED STENTS, AND BALLOON ANGIOPLASTY WAS BASED ON THE EXPERIENCE AND PREFERENCE OF THE NEUROINTERVENTIONALIST. IN RARE CASES, NONCOMPLIANT BALLOON ANGIOPLASTY WAS USED INTRAOPERATIVELY TO TREAT SEVERE SEGMENTAL STENOSIS (>70% VESSEL NARROWING) OF THE PARENT ARTERY BEFORE PED IMPLANTATION. INCOMPLETE APPOSITION OF THE DEVICE TO THE PARENT ARTERY WALL AFTER PED IMPLANTATION RESULTED IN IMMEDIATE COMPLIANT BALLOON ANGIOPLASTY. THIS COMPLIANT BALLOON ANGIOPLASTY WAS PERFORMED TO SECONDARILY DILATE THE SUBOPTIMALLY EXPANDED DEVICE AND GAIN GOOD WALL APPOSITION AFTER PED IMPLANTATION. RESIDUAL POOR WALL APPOSITION WAS NOTED IN SOME CASES DESPITE BALLOON ANGIOPLASTY AND IMPROVEMENTS IN POOR WALL APPOSITION. PAO WAS DEFINED AS COMPLETE OCCLUSION OF THE PARENT ARTERY ON POSTOPERATIVE IMAGES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: PAO WAS FOUND IN 14 ANEURYSMS. THE ANEURYSM COMPLETE OCCLUSION RATE WAS 79.6%. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT SEGMENTAL STENOSIS OF THE PARENT ARTERY BEFORE PED IMPLANTATION INTRAOPERATIVELY IN TWO CASES AND TO SECONDARILY DILATE A SUBOPTIMALLY EXPANDED DEVICE TO GAIN GOOD WALL APPOSITION AFTER PED IMPLANTATION IN 21 CASES. WHERE BALLOON ANGIOPLASTY WAS IMMEDIATELY USED TO SECONDARILY DILATE A SUBOPTIMALLY EXPANDED DEVICE TO GAIN GOOD WALL APPOSITION AFTER PED IMPLANTATION, 12 CASES GAINED GOOD WALL APPOSITION AND ONE (CASE NO 12) OF THESE SUBSEQUENTLY DEVELOPED PAO. IN THE OTHER NINE CASES, THERE WAS STILL RESIDUAL POOR WALL APPOSITION AND PAO DEVELOPED IN THREE OF THESE CASES (CASE NOS 7, 9, AND 13) DESPITE BALLOON ANGIOPLASTY IMMEDIATELY AFTER PED IMPLANTATION, AND AN IMPROVEMENT IN WALL APPOSITION WAS OBSERVED. IN ONLY TWO CASES WAS BALLOON ANGIOPLASTY USED TO TREAT SEGMENTAL STENOSIS OF THE PARENT ARTERY BEFORE PED IMPLANTATION INTRAOPERATIVELY, AND ONE (CASE NO 2) OF THESE SUBSEQUENTLY DEVELOPED PAO. THREE IAS DEVELOPED SYMPTOMATIC PAO WITHIN 1 MONTH AFTER PED IMPLANTATION (CASE NOS 2, 3, AND 8). IN CASE NO 2, PAO MANIFESTED AS DISTURBANCE OF CONSCIOUSNESS AND POSTERIOR CIRCULATION INFARCTION WITHIN 5 HOURS AFTER PED IMPLANTATION, LEADING TO SEVERE NEUROLOGICAL SEQUELAE. IN CASE NO 3, PAO MANIFESTED AS LIMB WEAKNESS WITHIN 15 DAYS AFTER PED IMPLANTATION. IN CASE NO 8, PAO MANIFESTED AS CEREBRAL INFARCTION AND LEFT HEMIPLEGIA WITHIN 7 DAYS AFTER PED IMPLANTATION. IN CASE NO 14, PAO MANIFESTED AS NEW NEUROLOGICAL DEFICITS WITHIN 5 YEARS AFTER PED IMPLANTATION. A TOTAL OF 10 IAS WERE INCIDENTALLY FOUND IN PATIENTS WITH ASYMPTOMATIC PAO WITH NO NEW NEUROLOGICAL DEFICITS ON ROUTINE FOLLOW-UP IMAGES WITHIN 6¿36 MONTHS AFTER PED IMPLANTATION. 'DELAYED' PAO WAS FOUND IN TWO IAS, WITH PREVIOUS POSTOPERATIVE IMAGES SHOWING IA OCCLUSION AND AN OPEN PARENT VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614889 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Disability| L