MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number PED2-400-35

Device Problem Migration (4003)

Patient Problems Infarction, Cerebral (1771); Headache (1880); Occlusion (1984); Paralysis (1997)

Event Date 08/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline migrated post-procedure and the patient experienced a cerebral infarction, paralysis, and headache.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 10mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy was performed, and the pru level was unknown.It was reported that implantation of the pipeline was performed on (b)(6) 2020.There was no problem observed on the ct after the initial procedure.It was noted the stent had opened evenly, and the ophthalmic artery, anterior choroidal artery side branch was covered by the pipeline.The patient was discharged after a two week hospital stay.Three days later, the patient was hospitalized for cerebral infarction, and it was found the distal end of the pipeline migrated from the middle cerebral artery to the anterior choroidal artery which was occluded.It was unknown when the migration occurred post-procedure, and it was in that state that paralysis remained at the time of the report.The patient also complained of headache due to a sudden thrombosis during hospitalization was a steroid was administered.According to confirmation after the patient was transferred to the hospital due to the cerebral infarction, the aneurysm was occluded by about half.

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 the paralysis remained due to the anterior choroidal artery occlusion.It was unknown what treatment the patient received for the occlusion.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10450055
• MDR Text Key: 204351758
• Report Number: 2029214-2020-00839
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: PED2-400-35
• Device Catalogue Number: PED2-400-35
• Device Lot Number: A839456
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/30/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability