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

Model Number	SFR4-3-20-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: 105-5081-153 (unknown); implant date n/a; explant date n/a.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
It was reported that during an intracranial thrombus removal procedure using the sfr4-3-20-10 stent, the device could not move forward in the microcatheter and had to be withdrawn.Upon examination, it was discovered that the push wire at the front end of the stent was bent, preventing normal use.There were no patient symptoms or complications associated with this event, and the patient outcome was reported as alive with no injury.
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 cause of the resistance was not determined.The resistance was near the middle of the catheter.A continuous saline flush was administered and maintained as indicated in the ifu.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) 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 reported rebar 18 catheter was not returned with the stent.Damaged location details: the solitaire fr4-3-20-10 stent¿s finger markers were examined inside the introducer sheath.All finger markers were aligned correctly, and no damages were noted.The stent¿s working and non-working lengths were in good condition.No irregularities were found outside the proximal marker.The marker coil appeared to be pulled back up to 0.475cm from the proximal marker, while the ptfe shrink tubing on the pushwire was accordioned from 7.0cm to 7.5cm from the distal tip.No defects were found on the pushwire.No other anomalies were found.Testing/analysis: due to its damaged condition, the returned solitaire fr4-3-20-10 stent device cannot be used for resistance testing.Conclusion: based on the reported information and device analysis, the customer¿s complaint was confirmed, as the returned solitaire fr4-3-20-10 stent device was damaged (marker coil pulled back and accordioned ptfe shrink tubing).The damages likely occurred when the customer attempted to advance the solitaire fr4-3-20-10 stent device through the rebar 18 catheter against resistance.The root cause cannot be determined.Possible causes include vessel tortuosity, incompatible/damaged catheter, and a lack of continuous flush with heparinized saline during delivery.In this event, the reported rebar 18 catheter was compatible with the solitaire fr4-3-20-10 stent device as it had a labeled inner diameter (id) of 0.018 inches, ruling out incompatibility as a possible cause.In addition, the customer stated that a continuous flush was administered; however, it was not specified if it was with heparinized saline.Therefore, we cannot rule out a lack of continuous flush with heparinized saline during delivery as a possible cause.Thus, vessel tortuosity, a damaged catheter, and a lack of continuous flush with heparinized saline during delivery could have contributed to the resistance complaint.Since the rebar 18 catheter was not returned, any contribution to the resistance issue could not be determined.H6.Coding updated based on analysis findings.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: 21035738
• Report Number: 2029214-2024-02459
• Device Sequence Number: 7573407
• 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): 03/03/2025

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: B657829
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 02/05/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/23/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown