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	Foreign Body In Patient (2687)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the solitaire became detached from the pushwire.The patient was undergoing surgery for treatment of an ischemic stroke in the left internal carotid artery.It was noted the patient's vessel tortuosity was moderate.The tici score was 0 at baseline and 2b at post procedure.There was 1 pass associated with this device.It was reported that the physician treated an acute ischemic stroke with a balloon guide catheter and prowler select plus microcatheter to deliver a 4x40 solitaire.When retrieving the clot with the solitaire the physician experienced resistance in the vessel.Solitaire became completely detached from the pushwire in the internal carotid artery before entering the balloon guide catheter.The physician retrieved the clot and the 4x40 solitaire with a 6x40 solitaire.The patient did not have vessel stenosis proximal to the thrombus site.The pushwire was not torqued during the procedure.There was no friction or difficulty during the procedure.The microcatheter tip did not cover the stent proximal marker during retrieval.The stent was removed from the patient.No surgical or medical intervention was required.The physician did not attempt to detach the stent.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The solitaire unit number is sfr4-4-40-10 no patient symptoms or complications were associated with this event.Ancillary devices include a prowler select plus microcatheter.
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), item:10,lotno:d022028 as found condition: the solitaire fr4-4-40-10 stent device was returned for analysis and was observed to be tangled with the returned solitaire fr4-6-40-10 stent device, inside a sealed biohazard bag, and a shipping box.The non-mdt (prowler select plus) microcatheter was not returned.Damaged location details: the solitaire fr4-4-40-10 stent¿s working length struts were observed to be tangled, while the non-working length struts were in good condition.No irregularities were found outside the proximal marker, and no defects were found on the marker coil.The pusher wire was observed to be broken at ~197.5 cm from the proximal end of the pusher wire.The broken end of the pusher wire was sent out for scanning electron microscopy (sem) failure analysis testing.No other anomalies were found.Testing/analysis: due to its damaged condition, the returned solitaire fr4-4-40-10 stent device cannot be used for resistance testing.The broken end of the pusher wire was sent out for scanning electron microscopy (sem) failure analysis.The sem results indicated that, based on the dimple rupture features and the necking profile, it is believed that the broken end failed via tension overload.Conclusion: based on the reported information, the customer¿s complaint was confirmed.It was observed that the working length struts were tangled, and the pusher wire was broken.The strut entanglement likely occurred when the solitaire fr4-6-40-10 stent device was used to retrieve the solitaire fr4-4-40-10 stent device.However, the cause could not be determined.In addition, the pusher wire was also found to be broken at ~197.5 cm from the proximal end of the pusher wire; it is believed to have failed via tension overload.Likely causes were retrieval friction with the microcatheter or hard clots.However, the cause could not be determined.Since the non-mdt (prowler select plus) microcatheter was not returned, any contribution of the catheter to the complaint 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.
Event or Problem Description
Additional information was received.The physician was unable to determine the exact cause of the event and could only speculate.A continuous catheter flush was administered during the procedure in accordance with the ifu.No kinks or damage were observed on the catheter.The tip of the solitaire sheath was confirmed to have been secured into the hub of the microcatheter.The characteristics of the clot were reported as unknown.
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 patient did not receive tenecteplase.

• 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: 22668989
• Report Number: 2029214-2025-01723
• Device Sequence Number: 14381765
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: (01)00763000425678(17)280226(10)D022028
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

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: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: D022028
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 09/19/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG