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

Model Number	PED2-375-14
Medical Device Problem Codes	Material Frayed (1262); Retraction Problem (1536); Material Deformation (2976); Unintended Movement (3026); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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 patient was undergoing treatment for a saccular, unruptured right internal carotid artery rica aneurysm with a max diameter of 5 mm and a 3 mm neck diameter.The landing zone was 2.8mm distally and 3.6mm proximally.  it was noted that the patient's vessel tortuosity was moderate. dual antiplatelet treatment (dapt) was administered.The pru level was 154.It was reported that the ped pipeline was being deployed in aneurysm but because of distal location in the ica, they decided to put the distal end of the ped in m1.It started to come back too proximally in deployment.Thus, they re-sheathed to reposition more distal.The procedure took lots of maneuvering and when they started deploying the pipeline again, it appeared either compressed or frayed.They took it out and put a different one in.The angiographic result post procedure was great.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information received reported that the cause of the damage was not determined.After beginning to deploy they dragged the pipeline back to the center of the aneurysm neck, but they dragged too far and then had to resheath an reposition.It was noted that this maneuvering may have caused the problem.The stent was not broken.It was hard to re-sheath and re-position.The catheter used was a phenom 27.
Additional Manufacturer Narrative
H3: product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361) drawing(s) referenced: dwgsfg15xxx-yyyy-zz rev.F as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield was returned within the phenom 27 catheter.Damage location details: the pushwire was extending out from catheter hub.In addition, the distal braid, and tip coil were deployed from catheter distal tip.No bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.The distal and proximal ends of pipeline flex shield braid were found fully opened and damaged.No flash or voids molded were observed in the hub.No damage was found with hub.No bent or kink was found with catheter body.No damage was found with phenom 27 catheter distal tip/marker band.No other anomalies were observed.Testing/analysis: the pipeline flex was pushed out from catheter without any issue.The total and usable lengths of phenom 27 catheter were measured to be within specifications the catheter was flushed with water and water was exited out from the distal tip.An in-house 0.026" mandrel was inserted through the catheter hub.The mandrel successfully passed through the catheter hub and tip with no issues.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have ¿movement during deployment¿ and ¿resistance during re-sheathing¿.The pipeline flex shield braid ends were found to be fully opened and damaged.No defect was found with pushwire.However, the root cause could not be determined.Possible causes include patient vessel tortuosity, high force delivery, incorrect braid sizing, catheter kick back, insufficient distal anchoring of braid and vasospasm, resistance during delivery/retrieval, ped/delivery system damage, catheter damage, user does not maintain continuous flush, user resheaths more than 2 times.It was noted that the patient's vessel tortuosity was moderate, which eliminates this factor out as potential causes.Additionally, the phenom 27 catheter could not be confirmed to have resistance during retrieval as no defect was found with phenom 27 catheter and no resistance was observed during testing.However, the root cause could not be determined.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: 24061724
• Report Number: 2029214-2026-00069
• Device Sequence Number: 15916490
• Product Code: OUT
• UDI-Device Identifier: 00763000284244
• UDI-Public: (01)00763000284244(17)280520(10)D040556
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: PED2-375-14
• Device Catalogue Number: PED2-375-14
• Device Lot Number: D040556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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: 77 YR
• Patient Sex: Female