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

Model Number NV UNK PIPELINE

Device Problem Migration (4003)

Patient Problems Headache (1880); Nausea (1970)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Chen, j., tao, m., han, j., feng, x., peng, f., tong, x., niu, h., ma, n., <(>&<)> liu, a.(2021).Pipeline embolization device for the treatment of unruptured intracranial dissecting aneurysms.Frontiers in neurology, 12, 691897.Https://doi.Org/10.3389/fneur.2021.691897 medtronic review of the literature article found a study in which 80 patients had pipeline embolization devices (peds) implanted for the treatment of intracranial dissecting aneurysms (idas).Ped only was used to treat 61 aneurysms and ped with adjunctive coil was used to treat 12 aneurysms.Successful ped deployment was achieved for all patients though 2 required a second attempt for successful deployment.Favorable outcome was noted to be 95%.The conclusion of the article was that reconstruction using a ped is safe and effective in the treatment of unruptured idas, showing favorable long-term clinical and angiographic outcomes.However, the complications of this treatment should be noted.Careful selection of appropriate patients and individualized antiplatelet therapy might be needed.One patient, who had 2 peds implanted, developed severe progressive headache and vomiting 4 days post-operative.Digital subtraction angiography (dsa) showed the peds had fallen into the aneurysm.A basilar artery sacrificeprocedure was performed and the patient had an uneventful recovery with modified rankin scale (mrs) of 2 at discharge and remained the same at follow-up.

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.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13485622
• MDR Text Key: 294666397
• Report Number: 2029214-2022-00175
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

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 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: 01/28/2022
• Initial Date FDA Received: 02/08/2022
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male