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

Model Number	PED2-500-20
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
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
Medtronic received a report that the distal end of the mesh stent could not open.The middle section of the stent was deployed, but the front end remained unopened.Ultimately, the catheter was unable to retrieve the stent.After more than two attempts to retrieve it, the issue remained unresolved.Therefore, both were removed together and a complaint was filed.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an amorphous, unruptured left ophthalmic artery aneurysm with a max diameter of 6mm and a 4.6mm neck diameter.Landing zone: distal: 3.8mm and proximal: 4.9mm.Patient's vessel tortuosity was minimal.Access vessel was the femoral artery with a 10mm diameter.Patient was noted to have a medical history of hypertension.Dapt (dual antiplatelet treatment) was administered, pru level met the standard.The angiographic result post procedure showed blood flow was smooth.
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.The procedure was cancelled at the end of the operation.The distal dense mesh stent is failing to open, not the proximal end.The cause of the failure to open and the resistance encountered was undetermined.Resistance was noted in the distal section of the catheter.No damage, such as kinking, stretching, or separation, was observed on the pipeline pushwire or catheter.The device had not been placed in a vessel bend when the failure occurred.Resheathing was attempted as an additional step to open the pipeline, but the issue persisted.
Additional Manufacturer Narrative
Product analysis ¿ as found condition: the pipeline flex shield was found stuck inside the distal tip of the phenom 27 catheter, within a bio-hazard bag, and a shipping box.¿ damage location details: both the distal and proximal dps restraints were intact.The dps sleeves showed no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The braid's distal and proximal ends were not opened and frayed.The pushwire showed no bends, and there were no defects observed in the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.The catheter tip and marker were examined, with no damage found.However, the catheter body was found to be accordioned from 8.0 cm to 16.5cm from the distal tip.No other anomalies were observed.¿ testing/analysis: the pipeline flex shield was pushed out from the catheter lumen with difficulty.The total and usable length were measured within specifications.The catheter was flushed with water and found to be patent.It was then tested by running an in-house 0.026¿ mandrel through the catheter hub without issue; however, resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the customer report of "failure to open at the distal end" was confirmed, as the braid's distal and proximal ends were not opened and frayed.The cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, a damaged braid, or deployment of the braid in the vessel bend.The customer indicated that the vessel tortuosity was minimal and the braid was not positioned in the vessel bend, which rules these out as potential causes.It is possible that the damaged braid contributed to the failure to open.Braid damage can occur due to resheathing more than 2 times, over-manipulation, deployment technique, resistance encountered when advancing or retracting the delivery wire, or deploying/re-sheathing the braid against resistance.Additionally, the customer's report of "resistance during delivery/retrieval" was confirmed, as the pipeline flex shield was returned stuck inside the distal tip of the phenom 27 catheter.Both the pipeline flex shield and the catheter were found to have damage.The observed damage to the catheter (accordioning), braid (fraying), and hypotube (stretching) suggests that high force was applied.This damage may have resulted from the customer¿s attempts to advance or retrieve the pipeline flex shield through the catheter against resistance.However, the cause of the resistance could not be determined.Possible resistance cause includes a lack of continuous flush with heparinized saline during delivery.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: 22531596
• Report Number: 2029214-2025-01618
• Device Sequence Number: 20816360
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: (01)00763000284725(17)270422(10)B721745
• 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): 09/16/2025

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B721745
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/22/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG