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 Infarction, Cerebral (1771); Death (1802); Thrombus (2101)

Event Type  Death  

Manufacturer Narrative

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

Event Description

I.Saatci, k.Yavuz, c.Ozer, s.Geyik, h.S.Cekirge.Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow- up results.American journal of neuroradiology 33 (2012).Doi: 10.3174/ajnr.A3246.Background and purpose: flow-diverting devices now offer a new treatment alternative for cerebral aneurysms.We present the results of a large single-center series of patients treated with the ped, including long-term follow-up.Materials and methods: between november 2008 and september 2011, sidewall aneurysms with a wide neck (greater than or equal to 4 mm) or unfavorable dome-neck ratio (greater than or equal to 1.5); large/giant, fusiform, dissecting, blisterlike, and recurrent sidewall aneurysms; aneurysms at difficult angles; and aneurysms in which a branch was originating directly from the sac were treated with the ped.Patients were premedicated with dual antiplatelet medications.Data, including demographics, aneurysm features, clinical presentation, complications, results, and follow-up information, for up to 2 years are presented.Results: two hundred fifty-one aneurysms in 191 patients were treated.Of these, 96 (38.3%) were large or giant (greater than or equal to 10 mm).In 34/251 (13.5%), peds were used for retreatment.Adjunctive coiling was performed in 11 aneurysms (2.1%).The mean number of devices per aneurysm was 1.3.One aneurysm ruptured in the fourth month posttreatment (0.5%), and symptomatic in-construct stenosis was detected in 1 patient (0.5%) treated with percutaneous transarterial angioplasty.Any event rate was 27/191 (14.1%), with a permanent morbidity of 1% and mortality of 0.5%.Control angiography was available in 182 (95.3%) patients with 239 (95.2%) aneurysms.In 121 aneurysms (48.2%), 1- to 2-year control angiography was available.The aneurysm occlusion rate was 91.2% in 6 months, increasing to 94.6%.Conclusions: use of the ped is safe, efficacious, and durable in cerebral aneurysm treatment, with low morbidity-mortality and high occlusion rates as confirmed with mid- to long-term control angiography.Reported events.- one patient died due to thrombus formation in the right p1, resulting in brain stem infarct after placement of the ped extending from the left posterior cerebral artery to the basilar artery, jailing the right p1, to treat a wide-neck left superior cerebellar artery origin aneurysm.

• 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: 10129359
• MDR Text Key: 194359245
• Report Number: 2029214-2020-00527
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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): Death