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

Model Number	PED2-375-16
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured, tandem aneurysm in the ophthalmic segment of the internal carotid artery (ica) with a max diameter of 2.1 mm and a 3.2 mm neck diameter.Landing zone: distal: 3.71 mm and proximal: 2.96 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment administered.The angiographic result post procedure showed obvious contrast agent retention in the aneurysm, good stent adhesion, the blood flow in the blood vessels was smooth and the distal blood vessels had good blood supply.It was reported that this patient had a stenotic plaque in the middle cerebral artery, and the surgeon used phenom27 to deliver the stent to the anterior cerebral artery to deploy the shield.In the anterior cerebral artery, the tip end of the stent failed to open smoothly, and it still failed to open well after continued deployment.Then, it was pulled back to the bifurcation of the internal carotid artery and continued to deploy, but it still failed to open.During the continued attempts to deploy and retrieve the stent, the stent catheter fell below the proximal end of the aneurysm.Tried to push it to go upper again but failed.After the stent catheter was withdrawn as a whole, it was found that the tip end of the stent was damaged.It was reported the pipeline failed to open in the distal section.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient by resheathing and removing with the microcatheter.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-fg, implant date n/a; explant date n/a.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
Additional information was received that the reason why the stent cannot be opened may be due to the thinness of the deploying blood vessels and the poor overall condition of the patient's blood vessels.
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: product analysis of ped2-375-16, lotno:b620059.Damage location details: no bent or kink was found with pushwire.The hypotube was found to be slightly stretched.The shrink tubing was found intact but pulled back from the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The distal and proximal ends of pipeline flex shield braid were found to be fully opened and damaged.No other anomalies were observed.Conclusion: based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at the distal end as the distal and proximal ends of the pipeline flex shield braid were found fully opened and damaged.However, the root cause for damages could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18580246
• Report Number: 2029214-2024-00157
• Device Sequence Number: 18193644
• Product Code: OUT
• UDI-Device Identifier: 00763000284251
• UDI-Public: 00763000284251
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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: 08/31/2026
• Device Model Number: PED2-375-16
• Device Catalogue Number: PED2-375-16
• Device Lot Number: B620059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 01/27/2024; 03/21/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024; 04/18/2024
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10...
• Patient Age: 71 YR
• Patient Sex: Male