BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 17726720 · Received September 11, 2023

    Report

    Report Number
    2029214-2023-01654
    Event Type
    Death
    Date Received
    September 11, 2023
    Date of Event
    December 2, 2022
    Report Date
    September 11, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT RELATED TO REPORT: 2029214-2023-01653. 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

    ZHAO, LU, ZHANG, LI, SONG, GUAN, MAIMAITILI, WANG, FENG, WANG, WAN, MAO, SHI, YANG, LIU, AND ZHAO; STROKE VASCULAR NEUROLOGY; 2023; 0; PIPELINE EMBOLIZATION DEVICE FOR INTRACRANIAL ANEURYSMS PRESENTING WITH MASS EFFECT: A LARGECHINESE COHORT; DOI:10.1136/SVN-2022-002213. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS TREATED WITH PIPELINE STENTS HAVING COMPLICATIONS. THE STUDY AIMED TO ASSESS THE SAFETY AND EFFICACY OF PIPELINE EMBOLIZATION DEVICE (PED) TREATMENT FOR INTRACRANIAL ANEURYSMS PRESENTING WITH MASS EFFECT IN REAL-WORLD SETTINGS. SELECTED PATIENTS FROM THE PED IN CHINA POST-MARKET MULTI-CENTER REGISTRY STUDY WITH MASS EFFECT PRESENTATION. THIS STUDY INCLUDED 218 PATIENTS WITH A MEAN AGE OF 54.3 YEARS AND A FEMALE PREDOMINANCE OF 74.0% (162/218). OUT OF THE 268 ANEURYSMS IDENTIFIED IN THE 218 PATIENTS, ONLY 218 ANEURYSMS WERE TREATED WITH PED. THE MEAN ANEURYSM SIZE WAS 13.04± 9.76MM, AND THE AVERAGE NECK SIZE WAS 8.96±7.46MM, RESPECTIVELY. THE AVERAGE PARENT ARTERY DIAMETER WAS 3.94MM. AMONG THE 218 ANEURYSMS INCLUDED IN THE STUDY, 84.4% (184/218) WERE CLASSIFIED AS SACCULAR IN MORPHOLOGY, WHILE 15.6% (34/218) WERE CATEGORISED AS FUSIF ORM. MOST (89%, 195/218) OF THE ANEURYSMS WERE LOCATED IN THE PROXIMAL ANTERIOR CIRCULATION. IN COMPARISON, 11.0% (23/218) OF ANEURYSMS WERE SITUATED IN THE POSTERIOR CIRCULATION, WITH 1.4% (3/218) IN THE BASILAR ARTERY AND 9.1% (20/218) OBSERVED IN THE VERTEBRAL ARTERY AND OTHER VESSELS WITHIN THE POSTERIOR CIRCULATION. THE CLASSIC PED AND FLEX PED WERE USED IN SIMILAR PROPORTIONS (49.1%, 107/218 VS 50.9%, 111/218, RESPECTIVELY). APPROXIMATELY 4.6% (10/218) OF ANEURYSMS WERE TREATED WITH MULTIPLE PEDS. OF 218 ANEURYSMS, 41.7% (91/218) OF ANEURYSMS WERE TREATED WITH PED ALONE, WHILE 58.3% (127/218) OF ANEURYSMS WERE TREATED WITH PED AND COILS. OPERATORS AT EACH STUDY CENTRE USED THE PED AT THEIR DISCRETION. PATIENTS WERE TREATED WITH EITHER THE CLASSIC PED OR FLEX PED, DELIVERED AND DEPLOYED THROUGH A MARKSMAN MICROCATHETER.  PEDS WERE DEPLOYED SUCCESSFULLY IN 203 (93.1%, 203/218) CASES; 11 (5.1%, 11/218) WERE DEPLOYED SUCCESSFULLY AFTER ADJUSTMENT, WHILE 4 (1.8%, 4/218) FAILED TO DEPLOY. SUCCESSFUL DEVICE DEPLOYMENT AFTER ADJUSTMENTS WAS DEFINED AS THE SUCCESSFUL RELEASE OF THE PED AFTER TECHNICAL ADJUSTMENTS. THE PED WAS CONSIDERED SUCCESSFULLY DEPLOYED TO THE TARGET SITE WHEN IT WAS RELEASED AT THE INTENDED LOCATION WITHOUT REQUIRING ANY TECHNICAL ADJUSTMENTS. POSTOPERATIVE COMPLICATIONS INCLUDE MASS EFFECT DETERIORATION, POSTOPERATIVE HEMORRHAGIC STROKE (MAINLY INVOLVING DELAYED ANEURYSM R UPTURE OR DISTAL INTRAPARENCHYMAL HEMORRHAGE) AND POSTOPERATIVE ISCHAEMIC STROKE OR TRANSIENT ISCHAEMIC ATTACK (TIA). THE IMPROVEMENT OR DETERIORATION OF THE MASS EFFECT WAS DEFINED BY PATIENTS¿ SYMPTOMS. ISCHAEMIC POSTOPERATIVE COMPLICATIONS OCCURRED IN 14 PATIENTS (6.4%, 14/218) AFTER PED DEPLOYMENT, 8 PATIENTS (3.7%, 8/218) WERE ISCHAEMIC STROKE AND 6 PATIENTS (2.8%, 6/218) WERE TIA. THE POST-PED HAEMORRHAGIC STROKE RATE WAS 5.5% (12/218). THE MASS EFFECT WAS IMPROVED AND DETERIORATED IN 33.5% (70/218) AND 9.6% (21/218) OF PATIENTS IMMEDIATELY AFTER SURGERY, RESPECTIVELY. OF 21 PATIENTS OCCURRED MASS EFFECT DETERIORATION, 7 PATIENTS (33.3%, 7/21) WERE TREATED WITH PED ALONE AND 14 PATIENTS (66.7%, 14/21) RECEIVED COMBINED TREATMENT OF PED AND COILING. OVER A MEDIAN FOLLOW-UP PERIOD OF 8.4MONTHS (RANGE FROM 1 TO 48MONTHS), THE MORTALITY RATE OBSERVED WAS 2.8% (6/218). NINE (4.1%, 9/217) PATIENTS HAD COMPLETE OCCLUSION OF THE PARENT ARTERY DURING THE FOLLOW-UP PERIOD. POOR FUNCTIONAL OUTCOMES WERE OBSERVED IN 6.4% (14/218) OF PATIENTS DURING THE EARLY POSTOPERATIVE PERIOD AND 5.0% (11/218) OF PATIENTS DURING THE FOLLOW-UP PERIODS, RESPECTIVELY. APPROXIMATELY 71.6% (156/218) OF PATIENTS WERE OBSERVED MASS EFFECT RELIEF AT THE LAST FOLLOW-UP. THERE WAS NO SIGNIFICANT DIFFERENCES IN THE MASS EFFECT RELIEF RATE BETWEEN PATIENTS TREATED WITH PED ALONE (70.8%, 63/89) AND PED PLUS COILING (73.2%, 93/127). WITH A SHARP DROP-OFF IN MASS EFFECT PROPORTION AROUND THE 6MONTHS AFTER TREATMENT, THE RATE OF MASS EFFECT RELIEF APPROACHED 50% AT APPROXIMATELY 8MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231712 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 Death