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

Model Number	PED-475-25
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2020
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 information regarding a marksman catheter being used to deliver a pipeline that could not open and damage was found to both devices.The patient was being treated for an unruptured saccular aneurysm of the left posterior communicating artery.The aneurysm max diameter was 5.35mm and the neck diameter was 5.27mm.Vessel tortuosity was severe.It was reported that after one pipeline device failed to open and was removed with the catheter and both had became damaged, both devices were replaced and the procedure reattempted.When the marksman catheter reached the m2 segment of the middle cerebral artery, the pipeline flex was being delivered, the surgeon withdrew the marksman to the flat segment of m1, and released about 7-8mm of the pipeline.The tip of pipeline could not be opened, the surgeon tried to move it forward and backward, resheath and redeliver many attempts but still failed.The pipeline flex showed damaged burrs at the tip under development.The catheter tip was deformed and flat.When the catheter was withdrawn from the patient's body, it developed an accordion shape.The patient did not sustain any harm or injury during the procedure.
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.
Event or Problem Description
Medtronic received additional information: a smaller size pipeline device was used to treat the patient.The complaint pipelines were in the middle cerebral artery m1 and not in a bend.It was difficult to open the tip of the pipeline stents, attempted deploying in a longer length, swinging, and withdrawing.The catheter tips were not under stress.Images have been attached.
Additional Manufacturer Narrative
Investigation summary - it was reported that after failure of the first pipeline delivery with the marksman catheter, the devices were replaced with others of the same models and the procedure was reattempted.Again, after the marksman was navigated to aneurysm located and the pipeline was delivered but could not be opened at the distal end even after multiple attempts to move it, resheath and redeploy, etc.And then the pipeline showed burrs at the tip.The devices were removed from the patient's body.After the marksman was withdrawn, it developed an accordion shape.All devices had been prepared and used according to the instructions for use (ifu) and the catheter was flushed per ifu.A smaller pipeline was ultimately used to successfully treat the patient.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.The event was investigated to determine cause.Device return was requested, however the device was not returned at the time this investigation was completed and no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue and no dhr was requested, so a device history record review was not performed.Product return was impacted by the covid-19 outbreak.The event was processed following normal processes.Image review was completed in lieu of device return.Images of the pipeline flex braids and the marksman catheter were provided by the customer for review.In the images provided, the distal ends of the pipeline flex braids appeared to be opened and moderately frayed.In addition, the marksman catheter appeared to be accordioned.However, the images are not sufficient for analysis, therefore no conclusions could be drawn.After the pipeline was removed from the patient it was known that the braid was damaged which could contribute to the pipeline failure to open but may have also been caused during retrieval.As the patient was treated successfully with a smaller pipeline, the most likely cause of the device failure to open is that the braid was improperly sized to the patient's anatomy.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.See tr-nv12798 - pipeline flex compatibility.This event is similar to the existing investigation because there were issues with a procedure in which the pipeline flex and marksman microcatheter were used together.The root cause, if available, is documented in the referenced investigation record.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: 10010668
• Report Number: 2029214-2020-00408
• Device Sequence Number: 2793841
• Product Code: OUT
• UDI-Device Identifier: 00836462015883
• UDI-Public: 00836462015883
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2020

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: 01/14/2022
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: A766882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 06/03/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/08/2020; 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 56