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

Model Number NV UNK PIPELINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

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.Https://doi.Org/10.1093/neuros/nyaa309."abstract background: pipeline embolization device (ped; medtronic) ¿twisting¿ manifests with the appearance of a ¿figure 8¿ in perpendicular planes on digital subtraction angiography.This phenomenon has received little attention in the literature, requires technical precision to remediate, and has potential to cause ischemic stroke if not properly remediated.Objective: to report incidence, risk factors, and sequelae of ped twisting and to discuss techniques to remediate a ped twist.Methods: case images were reviewed for instances of twisting from a prospectively maintained, institutional review board-approved cohort of patients undergoing flow diversion for cerebral aneurysm.Results: from august 2011 to december 2017, 999 ped flow diverting stents were attempted in 782 cases for 653 patients.A total of 25 ped twists were observed while treating 20 patients (2.50%, 25/999).Multivariate analysis revealed predictors of twisting to be: large and giant aneurysms (odds ratio (or) = 9.66, p =.005; or = 27.47, p <(><<)>.001), increased ped length (or = 1.14, p <(><<)>.001), and advanced patient age (or = 1.07, p =.002).A p-value of.05 or less was deemed to be statistically significant.Twisted peds were able to be remediated 75% of the time, and procedural success was achieved in 90% of cases.Ped twisting was not found to be a significant cause of major or minor complications.However, at long-term follow-up, there was a trend towards poor occlusion outcomes for the cases that encountered twisting.Conclusion: twisting is a rare event during ped deployment that was more likely to occur while treating large aneurysms with long devices in older patients.While twisting did not lead to major complications in this study, remediation can be challenging and may be associated with inferior occlusion outcomes." the study involved review of cases occurring at a single facility between august 2011 and december 2017.782 procedures involving 653 patients occurred during which 999 pipelines were attempted to be placed.However, the final study information was regarding only the cases in which twisting of the pipeline was observed; this occurred with 25 pipeline devices in 20 cases.Average age of all patients included in the study was 56; the average age of patients who had twisting of the pipeline during the procedure was 67.A majority of patients (85%) in the study who had twisting of the pipeline during the procedure were female.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).Higher incidence of twisting also occurred more frequently in longer stents.Subarachnoid hemorrhage related to delayed rupture of the aneurysm occurred in one of the cases in the study.In one other case, a patient experienced brain stem perforator stroke that was considered possibly related to the pipeline apposition.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10929687
• MDR Text Key: 219523874
• Report Number: 2029214-2020-01217
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR