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

Model Number	PED2-350-20
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Retraction Problem (1536); Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (unknown); 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 patient was undergoing treatment for a saccular, unruptured the m2 segment of right middle cerebral artery aneurysm with a max diameter of 3.2 mm and a 2.6 mm neck diameter.It was noted that the patient's vessel tortuosity was moderate.The landing zone was 2.7mm distally and 3.5mm proximally.It was unknown if dual antiplatelet treatment (dapt) was administered.The angiographic result post procedure showed that there was significant retention of contrast agent in the aneurysm, and the stent was well apposed to the vessel wall.It was reported that the phenom 27 shapeable microcatheter.Based on the diameter of the middle cerebral artery, a pipeline flex f low-diverting stent ped was chosen for deployment.Both the inner and outer packaging were intact; after hydrating the stent, there was no resistance during delivery.The stent was deployed at the m1 segment of the middle cerebral artery, and its tip end was seen to be fully opened.During further deployment and manual contrast injection, stent migration was observed.It was decided to retrieve the stent and reposition and deploy it.However, the stent could not be retrieved, and on a subsequent attempt, it was found that the delivery wire had detached.Therefore, the stent and the shapeable microcatheter were withdrawn together into the intracranial support catheter and removed from the body.A new microcatheter and flow-diverting stent were then used instead for redeployment.The new stent's tip end was fully opened and well apposed to the vessel wall, and the aneurysm was well visualized on angiography.The procedure was then concluded, and the surgery was successfully completed.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.
Event or Problem Description
Additional information was received.Migration occurred because the stent retracted during the opening process.The cause of the delivery wire detachment was due to unloading between the rubber pad and the stent.The pipeline was not implanted at the intended location, and no damage such as break or kink was observed.Resistance was encountered when retrieving the stent after migration was noted, and the delivery wire detached during retrieval.No visible damage or deformation was found on the stent or microcatheter after removal, and all components were retrieved intact with nothing left inside the patient.The patient did not require any additional procedures or interventions as a result of this event, and no vessel injury, dissection, or other intraoperative complication was noted.
Additional Manufacturer Narrative
Update b5 and h6 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.
Additional Manufacturer Narrative
H3: product analysis ¿as found condition: the pipeline flex shield braid was returned for analysis within shipping box; within a plastic bio-pouch; and within an opened pipeline flex shield inner pouch.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: the braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found to be fully opened and damaged.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion based on the analysis findings, the customer¿s complaints could not be confirmed.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.The pipeline flex shield braid ends were found to be fully opened and damaged.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: 23454474
• Report Number: 2029214-2025-02326
• Device Sequence Number: 20804511
• Product Code: OUT
• UDI-Device Identifier: 00763000284183
• UDI-Public: (01)00763000284183(17)280414(10)D032857
• 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): 01/27/2026

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: PED2-350-20
• Device Catalogue Number: PED2-350-20
• Device Lot Number: D032857
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 01/14/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: 47 YR
• Patient Sex: Female