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 Problem Insufficient Information (4580)

Event Date 07/06/2020

Event Type  Death  

Manufacturer Narrative

The age provided in this report represents the median age of all patient included in this study literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Griessenauer, c.J., enriquez-marulanda, a., taussky, p., biswas, a., grandhi, r., xiang, s., hong, t., rinaldo, l., lanzino, g., brinjikji, w., burkhardt, j., kan, p., ghuman, m., yang, v.X.D., chen, k., aziz-sultan, m.A., ghorbani, m., schirmer, c.M., goren, o., dalal, s.S., killer-oberpfalzer, m., muller-thies-broussalis, e., koch, m.J., stapleton, c.J., patel, a.B., foreman, p.M., cress, m.C., hirschl, r.A., krings, t., zhang, h., dmytriw, a.A.(2020).Experience with the pipeline embolization device for posterior circulations aneurysms: a multicenter cohort study.Neurosurgery, 87(6), 1252-1261.Abstract background: the pipeline embolization device (ped; medtronic) has been used off label for the treatment of challenging posterior circulation aneurysms.Data on this modality are primarily limited to small retrospective single-center series.Objective: to assess safety and efficacy of this treatment by establishing an international, multicenter collaboration.Methods: consecutive posterior circulation aneurysms treated with the ped from 2012 to 2019 across 11 neurovascular centers were ret rospectively reviewed.Baseline demographics, aneurysm and treatment characteristics, complications, occlusion status, and functional outcome were assessed.Results: there were 149 posterior circulation aneurysms treated with ped in 146 patients.A total of 24 (16.4%) patients presented with subarachnoid hemorrhage.Most aneurysms were dissecting/blister (36.2%) in morphology, followed by saccular (35.6%) and fusiform (28.2%).The most common locations were the vertebral (51.7%) and basilar arteries (22.8%).Complete or near-complete occlusion (>90%) was achieved in 90.9% of aneurysms at a median follow-up of 12 mo.Dissecting/blister aneurysms were most likely to occlude (p =.06).Symptomatic neurologic complications occurred in 9.4% of aneurysms, associated with larger size, ruptured presentation, presentations with brain stem compression, cranial nerve palsy, or stroke.Favorable functional outcome (modified rankin score 0-2) was achieved in 86.2% of patients.There were 6 fatalities of which 4 occurred in aneurysmal subarachnoid hemorrhage patients.Conclusion: this multicenter study shows that ped for the treatment of posterior circulation is preferentially used for the treatment of fusiform and dissecting/blister aneurysm morphologies.Despite the challenges presented by these less-common morphologies, flow diversion may be performed with a neurologic complication rate of about 10% and favorable long-term aneurysm occlusion rates.Pli10: 6 patients included in the study died.1 patient reportedly died due to unrelated liver cirrhosis.4 patients in the study who died had subarachnoid hemorrhage prior to the pipeline procedure.Therefore, 5 patients died of causes that could have possibly been related to the procedure or device.

• 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: 10949844
• MDR Text Key: 219762678
• Report Number: 2029214-2020-01233
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• 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): Death
• Patient Age: 56 YR