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

Model Number NV UNK PIPELINE

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

Patient Problems Stroke/CVA (1770); Neurogenic Shock (2265)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Fujii, t., oishi, h., teranishi, k., yatomi, k., suzuki, k., & arai, h.(2020).Outcome of flow diverter placement for intracranial aneurysm with dual antiplatelet therapy and oral anticoagulant therapy. interventional neuroradiology, 26(5), 532¿538.Https:/ /doi.Org/10.1177/1591019920947878.This retrospective study evaluated the complications and obliteration rates after flow diverter placement in patients taking anticoagulants.A total of 155 cases were treated by pipeline flex placement for unruptured large and giant cerebral aneurysms in our hospital between october 2015 and june 2019.The groups of 8 patients taking anticoagulants before operation and 147 patients not taking anticoagulants were compared.Additional coiling was performed in one patient in the anticoagulant group, and 46 patients in the nonanticoagulant group.Distal p arenchymal hemorrhage was observed in no patients in the anticoagulant group, and 5 patients in the non-anticoagulant group.Symptomatic ischemic complications were observed in no patients in the anticoagulant group, and 9 patients in the non-anticoagulant group.Delayed aneurysm rupture was observed in 2 patients in the anticoagulant group, but none in the nonanticoagulant group.Additional treatment was given to 3 patients in the anticoagulant group, and 7 patients in the non-anticoagulant group.Postoperative worsening of neurological symptoms was observed in 2 patients in the anticoagulant group, and 6 patients in the nonanticoagulant group.At the time of the final follow up, incomplete obliteration was found in 6 patients in the anticoagulant group, and 40 patients in the non-anticoagulant group.No procedure-related deaths occurred in this study.

Manufacturer Narrative

H6: upon further review, patient code e233604 does not apply.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
• MDR Report Key: 10999331
• MDR Text Key: 221226210
• Report Number: 2029214-2020-01289
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR