MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-4-40-10
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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 a report that when the stent was retrieved into the intermediate catheter during thrombus removal, the stent body was separated from the push guidewire.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an ischemic stroke.There were 3 passes with the device.It was noted the patient's vessel tortuosity was moderate.
Event or Problem Description
Additional information received that the cause of the separation was not determined.There were 3 passes made with the solitaire prior to the separation.On the third time, the device was retrieved into the intermediate catheter and resistance was felt.The solitaire device was not torqued or repositioned during delivery or retrieval.The patient did not have vessel stenosis proximal to the thrombus site; thrombus was located at the bifurcation.The microcatheter tip covered the solitaire device proximal marker during the attempted retrieval.The blood clot was hard and was considered to be a cardiogenic thrombosis.The surgery did not completely remove the blockage, and some blood clots remained.The solitaire was removed from the patient.
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
Product analysis #(b)(4):¿ equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿ as found condition: the solitaire x revascularization device was returned for analysis within a shipping box; within a plastic bio- pouch; and within a dispenser coil.The micro catheter used in this event was not returned.In addition, the model and lot number were not provided.Therefore, compatibility could not be assessed.¿ damage location details: the solitaire x device was returned within its introducer sheath.The finger markers were aligned properly when examined within the sheath.No separation was found with pusher or stent.No defects were found with the marker coil or pushwire.Visual inspection showed no irregularities outside of the attachment zone area.The stent was found to be still attached to the pushwire.The stent non-working (tear drop) and working length struts were in good condition.No other anomalies were observed.¿ testing/analysis: the stent device was pushed out from within the sheath without issue.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿separation¿ and ¿resistance during delivery¿ could not be confirmed.No defect, and separation was found with returned solitaire x device.The micro catheter used in this event was not returned.In addition, the model and lot number were not provided.Therefore, compatibility could not be assessed.However, the root cause 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: SOLITAIRE FR4
• 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: 19536541
• Report Number: 2029214-2024-01079
• Device Sequence Number: 20917135
• Product Code: NRY
• UDI-Device Identifier: 00847536034709
• UDI-Public: 00847536034709
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183022
• 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): 01/28/2025

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 Expiration Date: 06/01/2026
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B573903
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided; 01/03/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/12/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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 Sex: Prefer Not To Disclose