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

Model Number	PED2-500-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that they tried opening device in m1 and would not open distally after several attempts.Body did open nicely but distal end crimped.The pipeline was not positioned in a bend and it was not stuck in the capture coil.More than 50% of the pipeline had been deployed when it failed to open.It was resheathed "less than or equal to 2 times." no additional steps or other devices required to open the pipeline.It got stuck in hub of phenom 27 upon resheathing and removing.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an indication that is approved and the pipeline and any accessory devices were prepared as indicated in the ifu.  the patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery with a max diameter of 8mm and a 5mm neck diameter.Landing zone was 4.2mm distal and 5.1mm proximal.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered, pru level was 110.Angiographic result post procedure was normal.  ancillary devices include a bmx guide catheter and a phenom 27 microcatheter.
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.
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 reporting the distal end of the pipeline was frayed.There was no damage observed to the phenom.There was no resistance with the pipeline.This information has been confirmed with the physician.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19447445
• Report Number: 2029214-2024-01016
• Device Sequence Number: 8539892
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: 00763000284718
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 04/02/2026
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: B542445
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/30/2024
• Date Device Manufactured: 04/03/2023
• 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 Sex: Male