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

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.

Manufacturer Narrative

The literature article pertaining to this event was omitted from the initial report.The article has been attached to this report.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.

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.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11614255
• MDR Text Key: 243777544
• Report Number: 2029214-2021-00390
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• 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 Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death