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

Model Number	PED2-450-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2024
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 the phenom 27 navigated into m1 with great difficulty due to size of aneurysm and severe tortuosity.Device was prepped and taken into the m1 where the doctor attempted to open the distal device.Recapture, different locations and heavy load were attempted to open the device distally.It remained constrained throughout all efforts in the distal end.The pipeline was not positioned in a bend, more than 50% of the pipeline had been deployed when it failed to open, it was resheathed more than 2 times.No additional steps were taken.Device resheathed and phenom were removed from the body.Pipeline deployed on backtable and the distal end remained constrained outside of the body.Physician opted to end the procedure and bring patient back to use vantage for more reliable distal opening when device approved at this facility.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an indication that is approved.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 left internal carotid artery with a max d iameter of 12mm and a 6mm neck diameter.Landing zone was 3.7mm distal and 4.4mm proximal.It was noted the patient's vessel tortuosity was severe.Dapt was administered, pru was 76.Angiographic result post procedure show untreated lica aneurysm.  ancillary devices include 8fr pinnacle 10am sheath, penumbra bmx 96 guide catheter, phenom27 microcatheter, synchro guidewire, and m icrovention sophia 6fr intermediate.

• 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: 19087184
• Report Number: 2029214-2024-00641
• Device Sequence Number: 7102522
• Product Code: OUT
• UDI-Device Identifier: 00763000284541
• UDI-Public: 00763000284541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B638808
• 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: 04/09/2024
• Initial Report FDA Received Date: 04/11/2024
• Date Device Manufactured: 10/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 114 KG