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

Model Number	SFR4-6-40-10
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a solitairex6-40 encountered resistance in the distal shaft of the phenom.Stent disconnection was also noted as the solitaire delivery pusher became disconnected when it was pulled into the phenom outside the body.The patient was undergoing thrombectomy for treatment of an ischemic cerebral infarction in the right m1.It was noted the patient's vessel tortuosity was moderate.The access vessel was the middle cerebral artery (mca)/internal carotid artery (ica) with a 2-5mm diameter.Tici (postoperative): no problems.The patient was treated with a tps.There were 2 passes for the solitaire.Time required from onset of cerebral infarction to revascularization/revascularize was about 1 hour.It was reported that after the product was deployed to the right m1 and successful revascularization was achieved, it was deployed at the occlusion of the right ica and the solitairex was collected into the phenom 21.However, when the solitairex was about halfway inserted into the phenom 21, it became impossible to retract it.During surgery, it was collected as is and the procedure was completed, but when it was pulled into the phenom 21 outside the body, the solitaire x delivery pusher became disconnected.There was no vascular stenosis proximal to the thrombus formation site.The physician did not apply torque to the delivery pusher.2 passes were performed with the same stent.There was no resistance or difficulties during the procedure.When the stent was collected, the proximal marker of the stent was located within the microcatheter.Stent location: removed from body.No additional surgical or medical procedures were performed.The surgeon did not attempt to dislodge the stent.The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a phenom21 (lot: 229955087) 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: as found condition: the solitaire fr4-6-40-10 stent device and the phenom 21 catheter were returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the solitaire fr4-6-40-10 stent¿s working and 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 broken at 40.2cm from the distal tip, and the ptfe outer jacket was accordioned at 161.5cm to 162.5cm from the proximal end of the pusher wire.Testing/analysis: due to its damaged condition, the returned solitaire fr4-6-40-10 stent device cannot be used for resistance testing.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: 22035881
• Report Number: 2029214-2025-01197
• Device Sequence Number: 21203290
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: (01)00763000425739(17)270911(10)B788453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B788453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: Female