MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number	PED-500-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2020
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, even after multiple resheathing attempts.As a result the device was removed from the patient.There were no related patient symptoms.
Event or Problem Description
The devices were prepared and used per the instruction for use (ifu).A continuous flush used during advancement of the ped.
Additional Manufacturer Narrative
H3: findings: pipeline flex braid was deployed inside a phenom 27 catheter.The pipeline flex pushwire was not returned.The total and usable lengths of the catheter were measured to be within specifications.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 fully opened and moderately frayed.No other anomalies were observed.Based on the analysis findings, the pipeline flex could not be confirmed to have failure/incomplete open as the distal and proximal ends of the braid were found fully opened and moderately frayed.However, the cause for damage could not be determined.It is likely that the moderate 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
• Common Device Name: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10397870
• Report Number: 2029214-2020-00792
• Device Sequence Number: 11444906
• Product Code: OUT
• UDI-Device Identifier: 00847536019669
• UDI-Public: 00847536019669
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2020

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: 03/23/2023
• Device Model Number: PED-500-16
• Device Catalogue Number: PED-500-16
• Device Lot Number: A997330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66