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

Model Number PED-500-35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Dyskinesia (2363); Partial Hearing Loss (4472)

Event Date 04/26/2021

Event Type  Death  

Manufacturer Narrative

Physician information is not reported due to region privacy laws.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information reporting that a patient who underwent a procedure for pipeline implantation had post-procedure complications.The patient's mrs pre-procedure was 3.Post-procedure mrs was 4.It was reported the patient had trunk ataxia, facial paralysis, and hearing loss post-procedure.The aneurysm was discovered after the patient experienced cranial nerve disorder and neurological symptoms with no prior history.An unruptured spindle-shaped aneurysm of the left vertebral artery with a max diameter of 47.7mm was observed.The patient underwent a procedure for flow diversion treatment on (b)(6) 2021 with a pipeline (model: ped-500-35, lot: b121666).Neurological symptoms were reported to occur on (b)(6) 2021.There was no allegation of any device malfunction or defect.Multiple other pipelines were included in the report information without any allegation; there was no information submitted in the initial information regarding the other pipelines.

Event Description

Additional information received reported an incomplete occlusion, additional placement was completed.

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.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received reported that the data 36 months post-procedure was updated and "mrs worsened (4 to 6)" and "outcome: patient death" was confirmed.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12067254
• MDR Text Key: 265204755
• Report Number: 2029214-2021-00775
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B121666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 03/06/2023; 03/24/2024
• Supplement Dates FDA Received: 03/10/2023; 04/16/2024
• 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): Disability; Death
• Patient Age: 56 YR
• Patient Sex: Male