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

Model Number	PED2-475-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received a report that a pipeline failed to open at the distal end.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured left ophthalmic artery segment aneurysm with a saccular morphology.Landing zone (artery size): distal 4.1 mm, proximal 4.6 mm.The patient¿s vessel tortuosity was moderate.The stent was delivered to the m1 segment and began to be deployed.The tip end could not be opened.After many adjustments, it still could not be opened.The product model was changed to complete the surgery.The pipeline was not positioned in a bend.The pipeline was not stuck in the capture coil.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than 2 times.The pipeline was resheathed and removed with the microcatheter.Dapt (dual antiplatelet treatment) was administered.Angiographic result post procedure: no effect.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received reported that the pipeline could not be opened even after operations such as pushing and pulling.The tip end could not be opened despite repeated adjustments under dsa.It was thought that this may be due to defects in the pipeline tip end itself.
Additional Manufacturer Narrative
H3.Product analysis: ¿ equipment used: video inspection system (m-78210), ruler (m-83361) ¿ as found condition: the pipeline flex shield embolization device was returned for analysis withing shipping box; and within a plastic bio-pouch.¿ damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The distal and proximal ends of pipeline flex shield braid end were found fully opened and damaged.No other anomalies were observed.¿ conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure/incomplete open distal (flex) as the distal and proximal ends of the braid were found to be fully opened and damaged.Damage to the braid identified during analysis, could have occurred due to resheathing of the pipeline flex shield more than two times.H6.Coding updated based on analysis findings.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.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received clarified that the additional pipeline and marksman that were returned were related to another complaint report.Because the extracorporeal recovery the pipeline could not be pushed out/pulled back from the marksman, so the marksman was cut off to withdraw the pipeline.
Additional Manufacturer Narrative
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: LASER THERAPY PRODUCT
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19069650
• Report Number: 2029214-2024-00608
• Device Sequence Number: 6900735
• Product Code: OUT
• UDI-Device Identifier: 00763000284657
• UDI-Public: 00763000284657
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 04/24/2026
• Device Model Number: PED2-475-30
• Device Catalogue Number: PED2-475-30
• Device Lot Number: B554109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2024
• Supplement Date Received by Manufacturer: 04/20/2024; 08/25/2024; 09/26/2024; 10/21/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/10/2024; 09/04/2024; 10/21/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 56 KG