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 Intracranial Hemorrhage (1891); Nerve Damage (1979); Vascular Dissection (3160)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Jiang, b., bender, m.T., westbroek, e.M., campos, j.K., lin, l.-m., xu, r., tamargo, r.J., huang, j., colby, g.P., & coon, a.L.(2018).Procedural complexity independent of p2y12 reaction unit (pru) values is associated with acute in situ thrombosis in pipeline flow diversion of cerebral aneurysms. stroke and vascular neurology, 3(3), 169¿175.Https://doi.Org/10.1136/svn-2018-000150 medtronic received a literature article pertaining to a cohort of 37 ped cases with acute in situ thrombosis (mean age 53.8 years, mean aneurysm size 8.4 mm) that was matched with a cohort of 705 ped cases without intraprocedural thromboembolic events (mean age 56.4 years, mean aneurysm size 6.9 mm).The two groups were evenly matched in patient demographics, previous treatment/subarachnoid hemorrhage (sah), and aneurysm location.The study took place between april 2011 and august 2017, during which a total of 742 consecutive ped/ped flex cases were performed.Of these 742 cases, 37 were identified to have acute in situ thrombosis intraprocedurally.The remaining 705 cases did not have acute ischaemic intraprocedural complications.Intraprocedural thromboembolic complications occurred in 10.8% of the in situ thrombosis group vs 1.2% of the control group.Of these major stroke (nih stroke scale>4) occurred in 4 patients of the in situ thrombosis group and 10 patients of the control group.Minor stroke (nih stroke scale <(><<)>4) occurred in 1 patient of the in situ thrombosis group and 6 patients of the control group.Dependent intracerebral hemorrhage occurred in 1 patient of the in situ thrombosis group and 7 patients of the control group.Remote in tracerebral hemorrhage occurred in 1 patient of the in situ thrombosis group and 1 patient of the control group.Cranial nerve palsy occurred in 9 patients of the control group.Iatrogenic dissection occurred in 1 patient of the in situ thrombosis group and 3 patients of the control group.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11490448
• MDR Text Key: 240354188
• Report Number: 2029214-2021-00293
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/15/2021
• 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; Required Intervention
• Patient Age: 55 YR