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

Model Number	PED2-425-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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 information that a ped2 pipeline failed to open.Pipeline would not open at the turn on the distal edge of the aneurysm neck.It failed to open in the middle section.The middle of the pipeline was positioned in a bend.More than 50% had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.No other actions were taken to open the pipeline.The pipeline was resheathed and removed from the patient with the micro catheter.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, saccular aneurysm in the right internal carotid artery (ica).The max diameter was 3.78mm and the neck diameter was 5mm.The distal landing zone was 3.5mm and the proximal landing zone was 3.78mm.Dual antiplatelet treatment was administered.Vessel tortuosity was moderate.No patient symptoms or complications were reported.Ancillary devices: 90cm ballast sheath, 058 navien guide catheter, phenom 27 microcatheter.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the pipeline flex shield braid was returned inside of a biohazard bag and a shipping box.¿ visual inspection/damage location details: the distal, middle, and proximal of the braid were found fully opened and no damage.No other anomalies were observed.¿ conclusion: based on the returned device, the customer complaint was not confirmed as the middle of the braid was fully opened and no damage.The cause of failure to open could not be determined.Possible causes of failure to open include vessel tortuosity and deploying the braid in the vessel bend.However, the customer reported that vessel tortuosity was moderate, ruling out vessel tortuosity as a potential cause.In this event, the user deployed the braid in the vessel bend may have contributed to the failure to open issue.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: 20413836
• Report Number: 2029214-2024-01824
• Device Sequence Number: 8390452
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: 00763000284459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 02/09/2025
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: B336875
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 53 KG