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

Model Number	PED2-425-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: phenom 27 microcatheter product id fg15150-0615-1s (lot: 231142603); echelon 10 microcatheter, product id unk-nv-echelon (lot: unknown); 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 a coil could not pass through the echelon 10 microcatheter at the anatomical tortuous section.Suspecting an issue with the catheter, the coil was replaced with another one, and the surgery proceeded smoothly, however, the pipeline flex with shield technology stent could not be deployed.The product was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing stent-assisted coil embolization surgery for treatment of an unruptured, middle cerebral artery aneurysm.It was noted the patient's vessel tortuosity was moderate.Femoral artery access vessel diameter was 8 mm.The angiographic result post procedure reported no issues.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).Ancillary devices included a phenom 27 microcatheter.
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.The lesion was c7 dissecting aneurysm with 5mm diameter.No problems were reported with the phenom 27 microcatheter.The main allegation regarding the ped2 stent was that it could not be opened, specifically at the distal section, although it was not placed in a vessel bend.Multiple attempts were made to open the stent, but they were unsuccessful, and the cause of the failure was determined to be a stent issue.When using the echelon 10 catheter with the coil, resistance was encountered in the distal section, but the coil came out of the introducer sheath smoothly.The instructions for use were strictly followed, and there was no kink or damage observed to either the coil or the catheter after removal.The cause of the resistance was determined to be a device issue.Both echelon 10 micro catheters had an issue with the coil.A total of five coils were used during this procedure, one of which could not pass through.Ancillary devices include a echelon 190-5091-150/0230721934, five coils apb-3.5-10-3d-es/229241635, apb-2-4-3d-es/230393655, apb-2.5-4 -3d-es/229241592, apb-1.5-2-3d-es/229728836, apb -1.5-2-3d-es/230592114.
Additional Manufacturer Narrative
H3:product analysis: ¿ equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿drawing(s) referenced: (b)(4) rev.F ¿ as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within shipping box; and within a plastic bio-pouch.The pipeline flex shield pushwire was returned outside the phenom 27 catheter.However, the braid was stuck within the phenom catheter hub.¿ damage location details: no bent or kink was found with pushwire.However, the pushwire was found to be separated/broken proximal to the dps sleeves.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.No damage was found with pads.The tip coil and dps sleeves were not returned for analysis, and the reason was not provided.The distal and proximal ends of braid were found to be fully opened and damaged.No flash or voids molded were observed in the hub.No bent or kink was found with catheter body.The catheter tip, marker band were examined; and no damage was found.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was cut to remove the pipeline flex shield braid from the catheter hub.The catheter was flushed with water and water exited out of the distal tip.The broken end was sent out for sem (scanning electron microscopy) analysis.¿ conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure to open at distal as the distal braid end was found fully opened and damaged.However, the root cause could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.The pipeline had not been placed in a vessel bend when it failed to open and the patient's vessel tortuosity was moderate.Which eliminates these factors out as potential causes.Additionally, the pushwire was found to be separated/broken proximal to the dps sleeves.However, the root cause could not be determined.Per the sem result, the broken end exhibits fracture features consistent with a torsional overload failure.Possible causes of the pushwire break/separation include vessel tortuosity, over manipulation, high force use, resistance during delivery/retrieval, or user resheaths more than 2 times.There is no complaint against the phenom 27 catheter.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.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: 24192554
• Report Number: 2029214-2026-00165
• Device Sequence Number: 15470189
• Product Code: OUT
• UDI-Device Identifier: 00763000284435
• UDI-Public: (01)00763000284435(17)280903(10)D062313
• 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: 2026
• Device Explanted Year: 2026
• 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): 04/28/2026

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: PED2-425-16
• Device Catalogue Number: PED2-425-16
• Device Lot Number: D062313
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/03/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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 Sex: Female