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

Model Number	PED2-400-30
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536); Structural Problem (2506); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Rupture (2208)
Date of Event	05/15/2025
Type of Reportable Event	Death
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
It was reported that during an initial implant procedure using the pipeline embolization device 4.00mm x 30mm for multiple unruptured, saccular aneurysms located in the posterior communicating segment of the left internal carotid artery (ica), several complications occurred.The aneurysms included an upper posterior communicating artery aneurysm measuring 7.1mm in maximum diameter with a 5.8mm neck, and another aneurysm approximately 5mm in size below.The distal landin zone was 3.3mm and the proximal landing zone was 3.9mm.The vessel exhibited severe tortuosity.Following femoral artery puncture, a 6f 90cm long sheath, 6f 115cm tethys guide catheter, phenom 27 microcatheter, and a 0.014 inch 200cm guidewire were used to access the target site.The devices were prepared according to the instructions for use (ifu).3d rotational angiography was performed to guide device selection and placement.The stent was hydrated and delivered, with the tip opened at the m1 segment of the middle cerebral artery.During pull-back positioning, the stent could not be anchored due to a short anchoring distance, resulting in stent retraction.When attempting to retrieve the stent for repositioning, excessive resistance was encountered.Subsequently, a rapid rise in blood pressure was observed, and angiography revealed rupture and bleeding of the internal carotid artery with subarachnoid hemorrhage.Pupillary dilation was noted on the operating table.Craniotomy was performed as a rescue intervention, but the rescue was unsuccessful and the patient died.
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 that the problem occurred that day and the patient died.The patient passed away at (b)(6), doctor informed that the patient died in the hospital.No autopsy records will be available.The patient's death may be related to the pipeline shield, and it may also be related to the operator's operation.There was intracranial aneurysm leading up to the patient's death.The cause of the resistance during retrieval may be vascular tortuosity.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield was returned inside the inner pouch, biohazard bag, and shipping box.The catheter was not returned.Visual inspection/damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The braid's distal, middle, and proximal were found open, with no damage.No bends were found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad, or the proximal bumper.No other anomalies were observed.Testing/analysis: n/a 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: 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: 22104668
• Report Number: 2029214-2025-01257
• Device Sequence Number: 8205608
• Product Code: OUT
• UDI-Device Identifier: 00763000284381
• UDI-Public: (01)00763000284381(17)270219(10)B694848
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2025

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: PED2-400-30
• Device Catalogue Number: PED2-400-30
• Device Lot Number: B694848
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/11/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG