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

Model Number	PED2-475-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received that the procedure was completed by implanting a pipeline vantage successfully.The cause of the pipeline failure was determined.
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
Continuation of d10: product id ped2-500-14 (b399984); product type: date 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 pipeline failed to open at the distal end.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured paraopthalmic aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 2.5 mm and  neck diameter 2.5 mm.Landing zone (artery size): distal 3.8 mm and proximal 4.8 mm.The vessel tortuosity was minimal.The physician tried to deploy 5.00 x 14 and 4.75 x 16 in vessel.The distal end would not open and physician tried multiple resheaths and repositioning to open distal end.Both times the products were removed from the catheter with no issue. the pipeline was positioned in the middle of the bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than two times.No additional steps or other devices were required to open the pipeline.The pipeline was removed from the patient.The pipeline was resheathed and removed with the microcatheter.Dapt (dual antiplatelet treatment) was administered (pru level was unknown).The angiographic result post procedure: no injury to vessel or patient.There were no patient symptoms or complications associated with this event.  ancillary devices: sheath rist 100cm 7f, guide catheter naven 125cm 058, microcatheter phenom 27 150cm.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the braid was returned inside a plastic jar, a biohazard bag and a shipping box.¿ visual inspection/damage location details: the distal and proximal ends of the braid were opened and frayed.¿ testing/analysis: n/a ¿ conclusion: based on the returned device, the customer complaint was not confirmed, as the distal and proximal ends of the braid were opened and frayed.The cause of the failure to open could not be determined.Possible causes include vessel tortuosity, damaged braid, and the user deploying the braid in a vessel bend.However, the customer reported that vessel tortuosity was minimal, ruling out the vessel tortuosity as a potential cause.In this event, the damaged braid and user deploying in a vessel bend may have contributed to the failure to open.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.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: 20388882
• Report Number: 2029214-2024-01803
• Device Sequence Number: 6416087
• Product Code: OUT
• UDI-Device Identifier: 00763000284619
• UDI-Public: 00763000284619
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2024

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: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: B763464
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided; 12/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/18/2024
• Date Device Manufactured: 07/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Female