MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE X; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-3-20-10
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular retrieval procedure, the stent sfr4-3-20-10 experienced several issues.Initially, there was significant resistance when the stent entered the microcatheter, although it eventually went in.The thrombus was not completely removed, and it was discovered that the first section of the stent was broken.Upon attempting to re-enter the microcatheter, the stent could not be inserted.After removal, it was found that the stent was severely deformed and could not enter the microcatheter.No patient complications have been reported as a result of this event.
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
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 reported that the cause of the resistance/damage was not determined.The patient¿s baseline (tici, n ihss etc.): tici level 1, nihss 9 points.The patient¿s post-thrombectomy condition (tici, nihss, etc.): tici level 3, nihss 1 point.The stent was kinked and severely deformed.A continuous saline flush was administered and maintained as indicated in the ifu.
Additional Manufacturer Narrative
Product analysis: as found condition: the solitaire fr4-3-20-10 stent device was returned for analysis inside a sealed biohazard bag and a shipping box.The rebar catheter was not returned.Damaged location details: the solitaire fr4-3-20-10 stent¿s working length strut was broken.The middle and non-working lengths struts were in good condition.No irregularities were found outside the proximal marker, and the marker coil was in good condition.No bends were found on the pusher, and no other anomalies were found.The broken end of the strut was sent out for sem analysis.Testing/analysis: the returned solitaire fr4-3-20-10 stent device could not be used for resistance testing due to its damaged condition.The broken end of the working length strut was sent out for scanning electron microscopy (sem) failure analysis.The sem results showed that the broken end failed via tensile overload.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: SOLITAIRE X
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: 21349578
• Report Number: 2029214-2025-00354
• Device Sequence Number: 18382428
• Product Code: NRY
• UDI-Device Identifier: 00763000367619
• UDI-Public: 00763000367619
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203358
• 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): 04/22/2025

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 Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B649146
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 03/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: Male