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

Model Number	PED2-475-30
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id ped2-450-35 (d046701); product id fg15150-0615-1s (231973615); 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
Medtronic received a report that the pipeline shield could not be anchored securely.The dense mesh stent was opened in the middle c erebral artery, then retracted to the target position, but it suddenly fell during the deployment process.The dense mesh stent was replaced, but it still fell into the aneurysm.Multiple attempts were unsuccessful.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The pipeline was used for an approved (on-label) indication.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for dense mesh stent implantation for aneurysm treatment of an amorphous, unruptured basilar artery aneurysm with a max diameter of 4.3 mm and a 3 mm neck diameter.The landing zone was 3.5 mm distally and 4.7 mm proximally.The access vessel was the femoral artery with a diameter of 4.9 mm.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was normal.The angiographic result post procedure was multiple aneurysms of the basilar artery.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 that there was no catheter kickback.It was noted that the report of "could not be anchored securely" referred to after deployment at the target site, it repeatedly dislodged.The cause of the event was not determined.Multiple pipeline devices were not being used when movement occurred.There was no friction or difficulty during delivery or positioning.The pipeline was not implanted at the intended location.The device did not jump and the tip of the catheter was not moved during deployment.It was noted the pipeline jumped during deployment.The tip of the catheter was not under stress.
Additional Manufacturer Narrative
B5: updated with new information received.H6: codes updated to reflect analysis completion.Product analysis # (b)(4): equipment used: video inspection system (m-85519), camera (panasonic lumix dmc-zs5); ruler (m-83361).Drawing(s) referenced: n/a.As found condition: the pipeline flex shield was returned inside a biohazard bag, and a shipping box.Visual inspection/damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation.The distal and proximal ends of the braid were found open and frayed.No bends were found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad, or proximal bumper.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the returned device, the customer report of "catheter kick back" and "difficult placement/positioning" was not confirmed.The cause could not be determined.Possible causes include high force delivery, over-manipulation, and resistance during delivery.The braid was also found to be frayed.The braid can become damaged due to resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause of the braid damage 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.
Event or Problem Description
Additional information received clarified that during deployment, the delivery system did not move, however, the pipeline stent jumped and fell down.

• 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: 23872739
• Report Number: 2029214-2025-02673
• Device Sequence Number: 5319359
• Product Code: OUT
• UDI-Device Identifier: 00763000284657
• UDI-Public: (01)00763000284657(17)280428(10)D035756
• 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): 02/18/2026

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: PED2-475-30
• Device Catalogue Number: PED2-475-30
• Device Lot Number: D035756
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 01/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 67 YR
• Patient Sex: Male