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

Model Number	PED2-500-16
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient had an aneurysm in the left c6 segment.The operator selected a shield 500-16 dense mesh flow-diverting stent.After the access was established, the stent was delivered to the ipsilateral m1.About 7¿8 mm of the stent tip was exposed, but after waiting approximately 10 seconds, the tip did not open.The operator continued to deploy the stent about 12 mm, but the tip still failed to open.Attempts were made to retrieve and redeploy the stent, including shaking and push-pull maneuvers, but the tip remained unopened.Adjusting the tension of the microcatheter also did not resolve the issue, so the stent was removed from the body.On inspection, the tip of the stent was found to be intertwined.The surgery was completed after replacing it with a shield 500-18 stent.During preparation for a second surgery, after successful microcatheter placement, difficulty was encountered in delivering the guidewire.After removal, a crease was found in the catheter.The procedure was completed successfully after replacing it with another catheter.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared and the catheters were 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 a saccular, unruptured intracranial left c6 segment aneurysm with a max diameter of 4mm and a 3mm neck diameter.Landing zone: distal: 4.5mm and proximal: 4.8mm.It was noted the patient's vessel tortuosity was moderate.Access vessel was the femoral artery with a 6mm diameter.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed a left ophthalmic artery aneurysm.Ancillary devices include a navien 6f115 guide catheter and phenom27 fg15150-0615-1s, 230755171, fg15150-0615-1s, 230663927 microcatheters.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 230755171); implant date n/a; explant date n/a product id fg151 50-0615-1s (lot: 230663927); 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
Additional information was received.All products were used on the same patient for the same event."during preparation for a second surgery" means that a kink was discovered in the catheter during the implantation of the second stent; the catheter was removed and replaced with a new one to complete the procedure.Additional information was received stating that the guidewire was not a medtronic product.The intertwined tip of the stent meant that it twisted.The cause of the event was not determined.The pipeline had not been placed in a vessel bend when it failed to open.Additional attempts were made to retrieve and push/pull, etc.It was specifically noted that phenom with lot 230663927 had difficulty in delivering the guidewire and a crease being found.Regarding phenom lot number 230755171, after being withdrawn from the body, there were concerns about damage to the tip, so it was not used further.There were no device issues with the navien catheter.
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.
Additional Manufacturer Narrative
Product analysis ¿ 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 device was returned within the phenom 27 catheter.¿ damage location details: the pushwire was extending out from catheter hub.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 tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The distal and proximal ends of pipeline flex shield braid were found fully opened and damaged.The pipeline flex shield braid was not twisted.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 pipeline flex shield device was pushed out from catheter without any issue.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out of the distal tip.¿ conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal and twisted as the device was resheated.In addition, the pipeline flex shield braid ends were found fully opened and damaged.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.The customer indicated that vessel tortuosity was moderate, which eliminates this factor out as potential causes.However, the cause of the braid damage could not be determined.In addition, based on the analysis finding the phenom 27 could not be confirmed to have catheter kink/damage as no defect was found with 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.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: 23572530
• Report Number: 2029214-2025-02412
• Device Sequence Number: 10120403
• Product Code: OUT
• UDI-Device Identifier: 00763000284701
• UDI-Public: (01)00763000284701(17)280814(10)D058302
• 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): 01/26/2026

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: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: D058302
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 01/07/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/02/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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: 54 YR
• Patient Sex: Male