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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paralysis (1997); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Zaeske c, goertz l, dorn f, et al.Comparative analysis of the pipeline and the derivo flow diverters for the treatment of unruptured intracranial aneurysms¿a multicentric study. world neurosurgery.2021;145:e326-e331.Doi:10.1016/j.Wneu.2020.10.062 medtronic received a literature article pertaining to 62 patients with unruptured aneurysms who were treated with a pipeline device between 2011 and 2019.The average age of the patient's was 52 years, with 55 female and 7 male.Multiple devices were used in 22 patients.Procedural adverse events occurred in 4 cases, including 3 thromboembolic events and 1 hemorrhagic event.Morbidity occurred in 2 total patients.There was no related mortality.There were 2 cases of ischemic stroke.The first patient developed an acute minor paresis of the right leg.Computed tomography angiography revealed acute in-stent thrombosis.Due to minor neurologic sequelae, nihss = 2, and anticipated good collateralization, no further recanalization attempt was conducted.Magnetic resonance imaging showed few punctuate embolic infarctions in the middle cerebral artery territory.At 6-month follow-up, the patient was asymptomatic with mrs = 0.The second patient exhibited an intradural left-sided internal carotid artery aneurysm.After the treatment, the patient suffered moderate right-sided hemiparesis.An immediately initiated digital subtraction angiography did not show any thromboembolic complications, but magnetic resonance imaging revealed several foci of thromboembolic infarctions.The patient recovered partially until 6-month follow-up, showing mrs = 2.

• 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: 11781066
• MDR Text Key: 249265808
• Report Number: 2029214-2021-00545
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/05/2021
• 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
• Patient Age: 52 YR