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

Model Number	PED2-425-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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 stent failed to open in the proximal section.The healthcare provider (hcp) advanced and started to deploy the 4.25x12 pipeline.The device opened well distally and pulled back into position distally.The device was then deployed more and the fellow packed a bit too much at the neck of the aneurysm, which was the widest area in the deployment zone.The device never opened well proximally after that.It was recaptured and not packed asmuch at the neck, but still flattened proximal to the aneurysm.The device was taken out without issue and a 4.25x14 was placed without incident.The discarded 4.25x12 looked normal when removed.A staff member accidentally threw it away after the procedure.More than 50% had been deployed when it failed to open.The pipeline was resheathedmore than 2 times.The pipeline was resheathed and removed the patient with the microcatheter.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 6mm and the neck diameter was 4mm.The distal landing zone was 3.8mm and the proximal landing zone was 4.18mm.Vessel tortusoit ywas moderate.Dual antiplatelet treatment was administered.The result post procedure was good result after deployment of 4.25 x 14 pipeline.No patient symptoms or complications were reported.
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 was received that the portion of the pipeline that would not open was in a vessel bend.The device was resheathed and redeployed to the resheathing marker more than once.All the usual methods were used to try to open it.The catheter was pulled back off the outer wall, the system was pushed forward, the wire was pushed, the device was unsheathed, but nothing worked.The device was taken out without being deployed and another device was deployed without incident.

• 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: 20154039
• Report Number: 2029214-2024-01525
• Device Sequence Number: 15511978
• Product Code: OUT
• UDI-Device Identifier: 00763000284411
• UDI-Public: 00763000284411
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2024

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 Model Number: PED2-425-12
• Device Catalogue Number: PED2-425-12
• Device Lot Number: B758905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 07/12/2024
• 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 Sex: Female
• Patient Weight: 64 KG