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

Model Number PED-275-20

Device Problem Material Deformation (2976)

Patient Problems Stroke/CVA (1770); Dysphagia/ Odynophagia (1815); Paralysis (1997); Dysphasia (2195); Obstruction/Occlusion (2422); Cognitive Changes (2551)

Event Date 05/01/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline that was damaged/deformed during implantation and the patient suffered stroke wi th subsequent adverse symptoms.The patient underwent a procedure for flow diversion treatment of an unruptured 6.0 x 5.2 x 5.7 mm saccular aneurysm of the right middle cerebral artery (mca) bifurcation with neck measuring 3.1mm and a second aneurysm of the internal carotid m2 segment.It was reported that on (b)(6) 2019, the pipeline device was implanted using the device's provided delivery system.After the release of the device, angiography showed no flow, and later slow flow, and the was noted that the pipeline had ¿twisted,¿ ¿prolapsed¿ or ¿invaginated¿ after full deployment, leading to a ¿no flow¿ and then a ¿low flow" in the inferior portion of the patient's vessel.The physician made repeated attempts to retrieve the pipeline device employing two different balloons, a non-medtronic stent retriever, and a solitaire device but without success.Post-operative evaluation later on 1 may 2019 showed that the patient had experienced a stroke intra-operatively with post-operative assessment of no contraction and no movement in the left leg and left arm motor strength; moves not against gravity right leg motor strength; right arm moves against gravity; delayed right pupil reaction to light; pupils not equal round and reactive; and 10 glasgow coma score.Brain ct on (b)(6) 2019 showed expansion of the previously existing right basal ganglia infarct extending into the corona radiata measuring 3.3 x 1.2 cm.Assessment at 1259 on (b)(6) 2019 found that the patient had left central facial weakness, 5/5 on right, 0/5 on left/flaccid (significant for left hemiplegia), severe oropharyngeal d ysphagia, and mild to moderate dysarthria of speech and mild to moderate cognitive deficits with fair prognosis for rehab to increase functional communication and cognitive skills.The complaint noted that the patient sustain irreversible neurological brain damage resulting in significant cognitive, motor and sensory deficits, affecting functional and cognitive abilities.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that late last week the patient was transferred to in-house hospice due to worsening complications from their initial stroke (e.G.Inability to swallow), and then passed away on (b)(6) 2021.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11791173
• MDR Text Key: 249749082
• Report Number: 2029214-2021-00550
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536014671
• UDI-Public: 00847536014671
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: PED-275-20
• Device Catalogue Number: PED-275-20
• Device Lot Number: A501423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability
• Patient Age: 57 YR