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

Model Number	PED-475-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
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 pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured, opthalmic aneurysm with a max diameter of 6mm and a 3mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that after successfully placing the first pipeline, the physician went to put a second one in.However, the distal section of the second pipeline would not open.It was noted the middle and distal portions of the pipeline were positioned in a bend, less than 50% had been deployed, it was resheathed less than or equal to two times, and no additional steps were taken to try and open the pipeline.The device was removed from the patient.Post procedure angiographic results were very good.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation could not be confirmed.As received, the pipeline flex braid was deployed inside the medtronic catheter.The pipeline flex pushwire was not returned.The catheter tip and marker were examined; and no damages were found.No kink or damages were found with catheter body.No flash or voids molded were observed in the hub.The catheter was flushed with water and blood exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub to remove the braid.The mandrel successfully passed through the catheter hub and tip and the braid pushed out from the catheter with no issues.The distal and proximal ends of the braid were found partially opened due to severely frayed.No other anomalies were observed.Based on the analysis findings, the pipeline flex was confirmed to have failure/incomplete open distal (flex) as the distal and proximal ends of the braid were found partially opened due to severely frayed.It is likely that the severe vessel tortuosity may have contributed to the event.Based on the returned devices, there was no non-conformance to specifications identified that led to the reported issues.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 FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9683592
• Report Number: 2029214-2020-00109
• Device Sequence Number: 14087072
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: PED-475-10
• Device Catalogue Number: PED-475-10
• Device Lot Number: A766237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1