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

Model Number	PED2-475-14
Medical Device Problem Codes	Material Frayed (1262); Retraction Problem (1536); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (230505311); product type: 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 information regarding a phenom 27 microcatheter that had resistance and a pipeline that failed to open at the distal end and was damaged.The patient was undergoing a procedure via radial access for flow diverter treatment of a posterior communicating artery (pcom) unruptured saccular aneurysm.The aneurysm max diameter was 6mm and the neck diameter was 4mm.The distal landing zone was 4mm and the proximal landing zone was 4.8mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered with pru level 201 noted.It was reported that the devices were prepared and catheter flushed as indicated in the instructions for use (ifu).The physician was attempting to initiate deployment the pipeline in the m1 segment, then drag it down into the internal carotid artery (ica).However, during deployment, the distal end of the pipeline failed to open.Less than 50% of the pipeline was deployed when the failure to open occurred.The pipeline was not positioned in a bend.The pipeline was sheathed and redeployed three times but could not be opened successfully.The middle part was opened but the distal end was not.Aside from resheathing and redeploying, no other steps or devices were used to open the pipeline.After three deployment attempts, the distal end appeared frayed on imaging so the pipeline was resheathed and removed along with the microcatheter.In vitro, it was confirmed that the pipeline braid was frayed and a kink was also noted in the middle segment.It was unknown how the kink occurred but possibly may have occurred during removal.It was noted that there was resistance in the middle of the phenom 27 microcatheter during the procedure.The pipeline was replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event; post procedure angiography results were "great.".
Event or Problem Description
Additional information was received stating that the catheter resistance was noticed during retrieval.No damage to the pipeline pushwire or catheter was observed.The information is confirmed by the physician.
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
H3: product analysis as found condition: the phenom 27 catheter and pipeline flex shield braid were returned for analysis within a shipping box; and within a plastic bio-pouch.However, the pipeline flex shield braid was stuck within catheter hub.The pipeline flex shield pushwire used in this event was not returned for analysis.Therefore, any contributing factors could not be assessed.Damage location details: no flash or voids molded were observed in the hub.No damage was found with hub.The pipeline flex shield braid was stuck in catheter hub and strain relief was found to be damaged.The catheter body was found to be kinked at ~37.8cm from the hub.The phenom 27 catheter tip and marker were examined; and was found to be flattened.The pipeline flex shield braid was found to be damaged.No other anomalies were observed.Testing/analysis: the total and usable lengths of phenom 27 catheter were measured to be within specifications.Unable to flush the catheter with water.The pipeline flex shield braid was stuck within catheter hub and unable to remove the braid.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure to open at distal as the pipeline flex shield braid was stuck within catheter and unable to remove the braid.In addition, the pipeline flex shield braid was found to be damaged.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.In addition, based on the analysis findings, the pipeline flex shield and phenom 27 catheter was confirmed to have resistance as the phenom 27 catheter and pipeline flex shield braid were found to be damaged.However, the root cause could not be determined.Possible cause includes patient vessel tortuosity, incompatible products, damaged catheter(s) (i.E.Kinked, bent), flush rate too low, catheter damage or device damages, guidewire or delivery system damage, material occludes catheter, insufficient catheter flushing or lack of continuous flush, and insufficient guidewire or delivery system hydration.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.
Event or Problem Description
Additional information was received stating that the catheter was not dissected in an attempt to remove the braid.
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.

• 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: 22010556
• Report Number: 2029214-2025-01172
• Device Sequence Number: 5342618
• Product Code: OUT
• UDI-Device Identifier: 00763000284602
• UDI-Public: (01)00763000284602(17)251026(10)B468957
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 10/26/2025
• Device Model Number: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: B468957
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/12/2025; 06/25/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/23/2025; 06/19/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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