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

Model Number	PED-500-20
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
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 after the marksman and pipeline (ped-500-20) were in place, the surgeon started to deploy the stent.However, a large resistance was felt, and the pipeline could not be pushed out of the microcatheter.After repeated adjustments, it still could not be pushed.It was also reported the distal end of the pipeline failed to open once it was able to be pushed past the resistance.The marksman and pipeline were removed together, and it was found the stent's tip and tail were found to be the shape of a fish's mouth.New products were then used to complete the procedure with no issue.Post-procedure angiography showed normal results.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery cavernous segment with a max diameter of 10 mm and a 6 mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.Ancillary devices include a 6f 115navien, and marksman microcatheter.
Event or Problem Description
Additional information received indicated the pipeline experienced resistance during deployment.Then it was able to be pushed out from the microcatheter, but the tip could not be opened.
Additional Manufacturer Narrative
H3: analysis of the pipeline flex braid subassembly (model: ped-475-25 lot: a766882) found no bends or kinks with the pipeline flex pushwire.The hypotube was found to be stretched within the introducer sheath and the ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be missing and not returned.The tip coil was found to be damaged.The pipeline braid was found to be missing and not returned.No other damages or anomalies were found with the device.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as both ends of the pipeline flex braid were found to be collapsed and frayed.The customer reported having re-sheathed the device more than 2 times.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.Based on the device analysis and reported information, the customer¿s report of ¿lockup/resistance at distal segment of catheter¿ was confirmed.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.However, the cause for the resistance could not be determined.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d1103.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.

• 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: 10733353
• Report Number: 2029214-2020-01054
• Device Sequence Number: 16425940
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 04/02/2023
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: B002749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR