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

Model Number	PED-500-35
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
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.It was reported that the stent was pushed out of the microcatheter in a kinked state and the middle section could not be opened.The pipeline had not been positioned in a bend and was more than 50% deployed when it failed to open.The pipeline was resheathed less than or equal to two times and was removed from the patient with the microcatheter and replaced.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the vertebral artery.The neck diameter was 13.4 mm.The patient¿s vessel tortuosity was normal.Dual antiplatelet treatment was administered, and the pru level was normal.
Additional Manufacturer Narrative
Product analysis #255470453:equipment used: video inspection system (m-77148), camera (panasonic lumix dmc-zs5) findings: the pipeline flex was returned within the dispenser coil; the inner pouch and outer carton; inside of a plastic bag and a shipping box.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex braid were found opened and moderately frayed.The middle section of the pipeline flex braid appeared fully opened and no damage.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open at the middle section as the middle portion of the pipeline flex was found fully opened with no damage.However, the cause for damage could not be determined.There was no non-conformance to specification that may have contributed to the failure to open issue.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: 10156291
• Report Number: 2029214-2020-00561
• Device Sequence Number: 19629421
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 08/27/2022
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: A890037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 65