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

Model Number	PED-400-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Headache (1880); Neurological Deficit/Dysfunction (1982)
Date of Event	06/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the target aneurysm was found due to a cranial nerve disorder with the patient.The aneurysm was treated with a pipeline on (b)(6) 2016 with no problems or adverse events during the procedure.On (b)(6) 2016 it was reported the patient experienced mass effect worsening, headache, and ocular motility disorder of a serious severity.It was reported there was no causal relationship with the equipment or procedure.The inflammation was determined to be caused by rapid thrombus formation of the aneurysm.The patient recovered on (b)(6) 2016.Six months post-procedure it was noted there was no more mass effect and the corrected rankin scale rating was 0.Aspirin and clopidogrel treatment was stopped at the three year follow up on (b)(6) 2019.The patient was undergoing surgery for treatment of a saccular aneurysm of the right c3 cavernous sinus with a max diameter of 29.4 mm and a 8.2 mm neck diameter.It was noted the patient's blood flow was xxx and vessel tortuosity was xxx.
Additional Manufacturer Narrative
B5: a sentence of "it was noted the patient's blood flow was xxx and vessel tortuosity was xxx." was included in error.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 or Problem Description
No additional information received.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10675904
• Report Number: 2029214-2020-01026
• Device Sequence Number: 11565301
• Product Code: OUT
• UDI-Device Identifier: 00836462015791
• UDI-Public: 00836462015791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2018
• Device Model Number: PED-400-25
• Device Catalogue Number: PED-400-25
• Device Lot Number: A158884
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 64