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

Model Number	PED2-450-12
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Retraction Problem (1536); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: fg15150-0615-1s (230455819); implant date n/a; explant date: 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.
Event or Problem Description
It was reported that during a neurovascular procedure for the treatment of an unruptured saccular aneurysm in the right internal carotid artery, ophthalmic segment, the pipeline embolization device end appeared frayed and the braid looked dislodged.The device was prepped according to the instructions for use and advanced into the hub of the catheter smoothly.However, upon advancing approximately 4 millimeters of the device into the middle cerebral artery, the distal end appeared abnormal.A single shot image confirmed the compromised integrity of the device, leading to the decision to remove it.During removal, resistance was felt, and the pusher wire snapped at the distal marker and ptfe sleeves.The device, distal tip coil, and ptfe sleeves remained in the phenom 27 catheter.T he device and associated components were saved within the catheter.Dual antiplatelet treatment was administered, and a different device was successfully deployed to treat the aneurysm.No patient complications have been reported as a result of this event.The aneurysm max diameter was 6mm, and the neck diameter was 3.6mm.The landing zone was 3.4mm distal and 3.1mm proximal.The patient's vessel tortuosity was minimal.The access vessel was the right ica, which was 5mm in diameter.
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 no pru level was noted from nursing staff.Medical history anxiety, tobacco abuse, hld, psoriasis, meth used in the past(20) yrs ago.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pipeline flex shield and phenom 27 catheter were returned inside the inner pouch, biohazard bag, and shipping box.¿ damage location details: the pushwire was found to be separated proximal to the dps sleeves.The tip coil and sleeves was found to be stuck inside the catheter.The distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the braid were found fully opened and frayed.No defects were found with the distal marker, re-sheathing marker, resheathing pad, or the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordioned at 9.5cm to 17.4cm from the distal tip.No other anomalies were observed.The broken end was sent out for sem analysis.¿ testing/analysis: the catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was tested by running an in-house 0.026¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub without issue; however, resistance was observed at the damaged locations.Per the sem results, the broken end failed via torsional overload.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 resistance was felt just distal to where the device pushed snapped.A continuous flush was used per instructions for use (ifu) to initially flush device and maintain flush through deployment.

• 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: 21563728
• Report Number: 2029214-2025-00611
• Device Sequence Number: 4373663
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: 00763000284503
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 05/01/2025

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: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B712041
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 04/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/03/2025; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 45 YR
• Patient Sex: Female