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

Model Number UNK-NV-PED2

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

Patient Problems Ischemia (1942); Stenosis (2263); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Xu c, wu p, han j, et al.Safety evaluation and flow modification in the anterior cerebral artery after pipeline embolization device deployment across the internal carotid artery terminus.Biomed research international.2021;2021:6657595.Doi:10.1155/2021/6657595.If information is provided in the future, a supplemental report will be issued.

Event Description

Xu c, wu p, han j, et al.Safety evaluation and flow modification in the anterior cerebral artery after pipeline embolization device deployment across the internal carotid artery terminus.Biomed research international.2021;2021:6657595.Doi:10.1155/2021/6657595.Medtronic literature review found a report of patient complications in association with a pipeline device.The purpose of this article was to explore the effect of a ped covering a1 on patients¿ clinical prognosis and to evaluate the factors related to vascular occlusion.A total of 48 patients were included in the present study; 31 patients were women, and 17 were men.The mean age was 54 years.The article does not state any technical issues during use of the pipeline.The following intra- or post-procedural outcomes were noted: -three patients experienced neurological deterioration at follow-up.One patient¿s right ica became stenotic after pipeline treatment; the mrs score was 1 before operation and 3 at the last follow-up.The second patient with a1 occlusion had an mrs score of 1 before operation and 2 at the last follow-up.The third patient had in-stent restenosis and cerebral ischemia; the mrs score was 0 before operation and 2 at the last follow-up.-the a1 segment was occluded in 11 patients, with diminished flow in 20 patients.

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 the adverse event mentioned in this article were not related to the medtronic device.Peds used in patients were all second-generation products.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 13502460
• MDR Text Key: 288798304
• Report Number: 2029214-2022-00194
• 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,Followup
• Report Date: 03/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-PED2
• Device Catalogue Number: UNK-NV-PED2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Female