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

Model Number NV UNK PIPELINE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

Li l, gao b-l, wu q-w, li t-x, shao q-j, chang k-t.Comparison of pipeline classic and flex embolization devices in endovascular performance for intracranial aneurysms.Medicine.2023;102(24):e34087.Doi:(b)(4).Medtronic literature review found a report of patient complications in association with pipeline embolization device.The purpose of this article was to investigate the endovascular performance of the pipeline classic embolization device (ped classic) and ped flex device (ped flex) in the treatment of intracranial aneurysms.Fifty-three patients with intracranial aneurysms treated with the ped classic were retrospectively enrolled into the ped classic group, and 118 patients with intracranial aneurysms treated with the ped flex were enrolled into the ped flex group.In the ped classic group, 58 ped classic devices were implanted, and 26 aneurysms underwent coil embolization.The group included 16 male and 37 female patients with a mean age of 55.7 years.In the ped flex group, 126 ped flex devices were implanted, and 35 aneurysms underwent concomitant coil embolization.The group included 40 male and 78 female patients with a mean age of 54.2 years.The success rate of the stenting procedure was 100% in both groups.The following intra- or post-procedural outcomes were noted: pipeline classic:  - in one case the tip of the guidewire of the stent was separated and left at the bifurcation of the distal middle cerebral artery, which did not lead to aggravation of symptoms.

Manufacturer Narrative

Continuation of d10: product id nv unk pipeline (); product id nv unk pipeline (); product id nv unk flex (); g2: citation: authors: li, l., gao, b.-l., wu, q.-w., li, t.-x., shao, q.-j., chang, k.-t.Comparison of pipeline classic and flex embolization devices in endovascular performance for intracranial aneurysms.Medicine 102(24):e34087 2023.Doi:(b)(4).Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.See manufacturer report # 2029214-2023-01639 and 2029214-2023-01640 for other reports from this article.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: 17724351
• MDR Text Key: 323919857
• Report Number: 2029214-2023-01641
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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
• Date Manufacturer Received: 08/22/2023
• 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
• Treatment: SEE H10...
• Patient Age: 54 YR
• Patient Sex: Female