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

Model Number	PED-400-20
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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 a pipeline experienced resistance in the marksman catheter and distal end failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ophthalmic artery segment.The max diameter was 8 mm, and the neck diameter was 5 mm.The landing zone was 3.8 mm distal and 4.2 mm proximal.The patient¿s vessel tortuosity was normal.The access vessel was the femoral artery and was 8 mm in diameter.Dual antiplatelet treatment had been administered, and the pru level was said to be 0.It was reported that pipeline had a relatively large resistance after it was pushed out of the microcatheter, and the tip couldn't be opened after adjustments.The device was replaced, and the procedure was successfully completed.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Angiographic results post procedure showed slow blood flow in the aneurysm.
Event or Problem Description
Additional information received from the physician noted that the resistance was felt approximately 20cm from the distal end of the catheter.There was no damage to the pipeline or catheter.The pipeline could not be opened in a straight part ofthe vessel, even after attempts to move it backward and forward.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: the pipeline flex stuck inside the marksman was returned.The pipeline flex could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex from the catheter lumen.No bends or kinks were found with the pipeline flex pusher.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, or with the distal marker or tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The pipeline flex braid was not found with the pusher.The reason for the braid not returning was not provided.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.The catheter body found to be accordioned at 18.5cm to 29.5cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.No other anomalies were observed.Based on the analysis findings, the pipeline flex and marksman were confirmed to have resistance during delivery as the returned pipeline flex was stuck inside the distal segment of the marksman catheter.In addition, the pipeline flex and the marksman catheter were found to be damaged.From the damages seen on the catheter body (accordioning), and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against resistance.However, the pipeline flex was not confirmed to have failure to open at the distal end as the pipeline flex braid was not returned.Possible causes of failure to open includes patient tortuous anatomy and damage to the braid.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: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10935594
• Report Number: 2029214-2020-01222
• Device Sequence Number: 16383837
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2021

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: 07/25/2023
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: B059600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/13/2020; 02/18/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/06/2021; 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 70