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 Edema (1820); Hemorrhage, Cerebral (1889); Therapeutic Response, Decreased (2271)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Adam a.Dmytriw, nimer adeeb, ashish kumar, christoph j.Griessenauer, kevin phan, christopher s.Ogilvy, paul m.Foreman, hussain shallwani, nicola limbucci, salvatore mangiafico, caterina michelozzi, timo krings ,md, vitormendes pereira,md, charles c.Matouk, yuchen zhang, mark r.Harrigan, hakeem j.Shakir, adnan h.Siddiqui, elad i.Levy, leonardo renieri, christophe cognard, ajith j.Thomas, thomas r.Marotta.Flow diversion for the treatment of basilar apex aneurysms.Neurosurgery 83 (2018).Doi:10.1093/neuros/nyx628.Background: flow diversion for basilar apex aneurysms has rarely been reported.Objective: to assess flow diversion for basilar apex aneurysms in a multicenter cohort.Methods: retrospective review of prospectively maintained databases at 8 academic institutions was performed from 2009 to 2016 to identify patients with basilar apex aneurysms treated with flow diversion.Clinical and radiographic data were analyzed.Results: sixteen consecutive patients (median age 54.5 yr) underwent 18 procedures to treat 16 basilar apex aneurysms with either the pipeline embolization device (medtronic inc, (b)(4)) or flow redirection endoluminal device (microvention, (b)(4)).Five aneurysms (31.3%) were treated in the setting of subarachnoid hemorrhage.Seven aneurysms (43.8%) were treated with flow diversion alone, while 9 (56.2%) underwent flow diversion and adjunctive coiling.At a median follow-up of 6 mo, complete (100%) and near-complete (90%-99%) occlusion was noted in 11 (68.8%) aneurysms.Incomplete occlusion occurred more commonly in patients treated with flow diversion alone compared to those with adjunctive coiling.Patients with partial occlusion were significantly younger.Retreatment with an additional flow diverter and adjunctive coiling occurred in 2 aneurysms with wide necks.There was 1 mortality in a patient (6.3%) who experienced posterior cerebral artery and cerebellar strokes as well as subarachnoid hemorrhage after the placement of a flow diverter.Minor complications occurred in 2 patients (12.5%).Conclusion: flow diversion for the treatment of basilar apex aneurysms results in acceptable occlusion rates in highly selected cases.Both primary flow diversion and rescue after failed clipping or coiling resulted in a modified rankin scale score that was either equal or better than at presentation and the technology represents a viable alternative or adjunctive option.Reported events.A (b)(6) male was undergoing surgery to treat a saccular aneurysm with a maximum dimension of 35 mm.The patient had a nondependent territory intracerebral hemorrhage that resolved without impact on mrs.A (b)(6) male was undergoing surgery to treat a saccular aneurysm with a maximum dimension of 27 mm.The patient developed perianeurysmal edema and mass effect; the only minor complication that affected mrs.Retreatment occurred with an additional flow diverter.A (b)(6) female was undergoing surgery to treat a saccular aneurysm with a maximum dimension of 10 mm.The patient experienced incomplete occlusion and required retreatment with an additional flow diverter.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10100847
• MDR Text Key: 200971951
• Report Number: 2029214-2020-00504
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• 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): Required Intervention