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

Model Number NV UNK PIPELINE

Device Problems Positioning Failure (1158); Activation Failure (3270)

Patient Problems Stroke/CVA (1770); Embolism (1829); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Loss of Vision (2139); Shaking/Tremors (2515)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Fei liang, yupeng zhang, feng guo, yuxiang zhang, peng yan, shikai liang, yuhua jiang, peng jiang, chuhan jiang.(2018).Pipeline em bolization device for posterior circulation aneurysms: single-center experiences with comparison with anterior circulation aneurysms, 112.Doi: 10.1016/j.Wneu.2018.01.129.Medtronic literature review found a report of patient complications after pipeline implantation.The purpose of the article was to evaluate the performance of the pipeline embolization device (ped) for posterior circulation aneurysms.The authors retrospectively reviewed the results of 35 patients with 38 posterior circulation aneurysms who underwent treatment with the ped and compared them to 163 anterior circulation aneurysms.The article describes the following posterior circulation aneurysm events: - out of the 37 procedures, 2 procedures encountered insufficient opening of the ped.It was stated that 2 malappositions occurred when the stenosis of the parent artery restricted the opening of the proximal part of the ped.These 2 cases ended up with parent artery occlusion.1 of the patients with bilateral dissecting aneurysms experienced postprocedural subarachnoid hemorrhage.It was decided to operate these aneurysms in 2 sessions and to deploy the ped in the dominant va (right) first.Subarachnoid hemorrhage was confirmed 1 day postprocedure by computed tomography scan with hyperdensity evident in the left sylvian fissure and ambient cistern.Clopidogrel was discontinued for 1 month until the left v4 segment aneurysm was treated.Because of the restriction by the stenosis of the parent artery, the ped was not fully opened even after angioplasty.Dsa follow-up after 7 months showed occlusion of the va, and the left posterior inferior cerebellar artery (pica) was patent with retrograde filling from the right side.Near occlusion of the parent artery occurred in the other case because the portion of the ped proximal to the stenosis did not fully expand.- 2 patients had minor ischemic stroke after the procedure.One of the patients harbored a vbj aneurysm; the patient presented transient blindness of the right eye, but the symptoms resolved 1 day later.The other patient with subacute cerebellar infarction and ataxia on admission experienced slight directional tremor postoperation.During the procedure, the pica was covered by the ped; however, the symptom of the patient completely relieved 2 days later.The article describes the following anterior circulation aneurysm events: - 3 patients experienced subarachnoid hemorrhage post preocedure.- 19 patients experienced minor ischemic stroke post procedure.- 6 patients experienced major ischemic stroke post procedure.- 1 patient experienced a delayed complication of intraparenchymal hemorrhage.- 3 patients experienced a delayed complication of parent artery occlusion.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• 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: 9168050
• MDR Text Key: 166669433
• Report Number: 2029214-2019-01000
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• 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