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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Positioning Failure (1158)
Patient Problems Intracranial Hemorrhage (1891); Rupture (2208)
Event Date 07/13/2020
Event Type  Death  
Manufacturer Narrative
Patient sex "female" is representative of the majority of patient's (85%) included in the study and does not necessarily represent the patient's information involved specifically in this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Bender, m. T. , young, r. W. , zarrin, d. A. , campos, j. K. , caplan, j. M. , huang, j. , tamargo, r. J. , lin, l. -m. , colby, g. P. , & coon, a. L. (2020). Twisting: incidence and risk factors of an intraprocedural challenge associated with pipeline flow diversion of cerebral aneurysms. Neurosurgery, 88(1), 25¿35. Https://doi. Org/10. 1093/neuros/nyaa309 medtronic review of the literature article found that in 782 cases for 653 patients, 999 flow diverting stents were tried. The study was regarding cases in which pipeline (ped) twisting occurred, which happened with 25 peds in 20 patients. The study also noted methods of addressing ped twisting and potential outcomes. 85% of the cases included in the study involved female patients and the average age was 67. In cases with twisting, the average size of the aneurysm being treated was 18. 1 mm, which was significantly greater than the average size of aneurysms in cases without twisting. Aneurysm locations in the twisting cohort was ica (80%), anterior cerebral artery (10%), and basilar artery (10%). Morphology was saccular in 70% of cases, fusiform in 25%, and dissecting in 5%. Prior to embolization, patients were treated with aspirin 325 mg and clopidogrel 75 mg daily for at least 5 d; antiplatelet therapy monitoring was not routinely performed. Embolizations were performed with systemic anticoagulation using heparin, through femoral access, and with a tri-axial system of catheters. Anatomic complexity was more frequently seen in cases with twisting, including significant cervical ica tortuosity (67% vs 31% in those without twisting) and grade iii or iv cavernous anatomy (50% vs 30% in those without twisting). The average diameter of twisted peds was greater than those without (4. 61 vs 4. 02mm) and the smallest diameter of a twisted ped was 3. 0 mm. The average length of twisted peds was also greater than those without (25. 96 vs 15. 83 mm) and the shorted twisted ped was 14mm. The 25 ped twists that we observed occurred in 20 cases. A total of 16 cases had 1 ped stent that twisted, 3 cases had 2 stents that twisted, and 1 case had 3 stents that twisted. The twisted stent(s) was remediated in 75% of cases (15/20 cases). Among the 5 cases that could not be remediated, a new stent was successfully deployed in 3 cases and 2 cases were aborted after a second stent twisted. When the procedure involved the placement of multiple stents, the majority of the time (7/8 cases) twisting occurred during the first attempted stent deployment. Several variables appeared to increase the risk of ped twisting, including large and giant aneurysm size, increasing stent length, and increasing patient age. There were a couple major complications, none of which could be statistically significantly associated to the pipeline twisting malfunction. However, contribution of the pipeline twisting or procedure could not be entirely ruled out as potentially contributing to the complications either. Pli10 - one patient in their 50's was treated for a 50mm fusiform aneurysm of the anterior cerebral artery (aca). The vessel was rec onstructed with 5 telescoping pipelines ranging from 3. 25-2. 75mm diameter and 25-35mm length. The first device tried was 3. 25mm x 30mm and was removed after it became twisted. The patient later experienced delayed aneurysm rupture leading to subarachnoid hemorrhage and death 4 months post-procedure.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11614255
MDR Text Key243777544
Report Number2029214-2021-00390
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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