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

Model Number	PED2-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
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 information that a ped2 pipeline failed to open.Tip end could not be opened.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, amorpous aneurysm in the left posterior communicating artery.The max diameter was 5mm and the neck diameter was 3mm.The distal landing zone was 4.4mm and the proximal landing zone was 4.9mm.Vessel tortuosity was moderate.The angiographic result post procedure was the stent was well attached to the wall.No patient symptoms or complications were reported.
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 received that the procedure was completed by replacing the new stent.The cause of the failure to open was not determined; suspected to be a protective sleeve binding the tip end.The distal section of the pipeline did not open.The pipeline had been placed in a vessel bend when it failed to open.It was attempted to retrieve and deploy, but failed.
Additional Manufacturer Narrative
Product analysis¿ equipment used: video inspection system (m-85519), camera (panasonic lumix dmc-zs5); ruler (m-83361) ¿ drawing(s) referenced: n/a ¿ as found condition: the pipeline flex shield was returned inside a biohazard bag and a shipping box.¿ visual inspection/damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation.The distal end of the braid was not opened due to the damaged braid.The proximal end of the braid was opened and frayed.No bends were found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the returned device, the customer complaint was confirmed that the braid's distal end was not opened due to a damaged braid.However, the cause for failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, damaged braid, or user deploying the braid in the vessel bend.The customer reported that vessel tortuosity was moderate, ruling out vessel tortuosity as a potential cause.The damaged braid and the user deploying the braid in the vessel bend may have contributed to the failure to open.The braid can become damaged due to resheathing more than two 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: 19452887
• Report Number: 2029214-2024-01023
• Device Sequence Number: 8500392
• Product Code: OUT
• UDI-Device Identifier: 00763000284749
• UDI-Public: 00763000284749
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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 Expiration Date: 08/13/2026
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B610446
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: Not provided; 07/18/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/28/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 75 KG