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

Model Number	PED2-500-10
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
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 in the distal section.5 x 10 pipeline was delivered through the phenom 27 out into the left m1.It was unsheathed but would not open.It was resheathed, redeployed pulled back close to the designated landing zone, and pushed out halfway.The midsection opened, but not the distal portion even after a fair amount of manipulation.The pipeline was not placed 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.The pipeline was resheathed and removed from the patient with the microcatheter.The devices were prepared according to the instructions for use (ifu).The catheter was flushed as indicated in the ifu.  the patient was being treated for an unruptured, amorphous aneurysm in the left pcom region.The max diameter was 6mm and the neck diameter was 3mm.The distal landing zone was 4.48mm and the proximal landing zone was 3.8mm.Vessel tortuosity was moderate.The access vessel was the left internal carotid artery (ica) with an access diameter over 5mm proximally.No patient symptosm 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 received reported the 5x10 pipeline got stuck in the original phenom 027 when it was being withdrawn from the patient close to the proximal end of the catheter.So, a second phenom was opened for the second device.The pipeline was resheathed twice and manipulated by pushing the system forward, releasing forward tension¿all the usual ¿tricks¿, nothing worked.The distal end never opened.

• 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: 19516876
• Report Number: 2029214-2024-01070
• Device Sequence Number: 8252168
• Product Code: OUT
• UDI-Device Identifier: 00763000284671
• UDI-Public: 00763000284671
• 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): 07/03/2024

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: 04/23/2026
• Device Model Number: PED2-500-10
• Device Catalogue Number: PED2-500-10
• Device Lot Number: B553375
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 04/24/2023
• 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: 74 YR
• Patient Sex: Female