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

Model Number	PED2-500-18
Medical Device Problem Code	Material Deformation (2976)
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
Product analysis # (b)(4): equipment used: video inspection system (m-85519), camera (panasonic lumix dmc-zs5); ruler (m-83361); as found condition: the pipeline flex shield braid was returned inside the inner pouch, a biohazard bag, and a shipping box.Visual inspection/damage location details: the braid's distal and proximal ends were opened and frayed.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the returned device, the customer complaint was confirmed as the distal and proximal ends of the braid were fully opened and frayed.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.Ls 2024-07-22.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
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 after the access was established, after intraoperative measurement and calibration, the ped2-5-18 stent was selected, the stent microcatheter was pushed to go upper to beyond m2, and then the stent was delivered.When the stent tip reached m2, the stent tip was slowly opened.However, once it came out of the microcatheter, the stent tip was damaged, so the stent was replaced.Ped2-5-20 was selected, but the stent tip still showed the same problem as the first stent.As soon as it came out of the microcatheter, the tip was found to be damaged.After retrieving and other operations, the stent tip could not be opened.Finally, ped2-475-20 was replaced, and the stent tip was successfully opened at one time, and the operation was successfully completed.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an indication that is approved and the pipeline and any accessory devices were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured left side, ophthalmic artery segment, cavernous sinus segment with multiple aneurysms.Max diameter was 3mm and neck diameter was 4mm.Landing zone was 4mm distally and 5.1mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered, pru level was "double antibiotics for 7 days before surgery." angiographic result post procedure showed significant retention of contrast agent in the aneurysm.

• 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: 19447818
• Report Number: 2029214-2024-01018
• Device Sequence Number: 19636926
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: 00763000284718
• 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
• Report Date (Section B): 08/19/2024

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: 04/24/2026
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: B554154
• 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: 07/23/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: 39 YR
• Patient Sex: Female