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

Model Number	SFR4-6-20-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received reported the patient was being treated for a right proximal m1 occlusion.Vessel tortuosity was normal.Nihss 3 with mild dysrrhythmia and facial droop on day 1 post op.Nihss 22 baseline.The phenom was not removed from the patient and replaced when the solitaire was removed due to product complaint, it was used with the new solitaire to successfully to deploy the stent and remove the clot.No patient symptoms were reported related o the resistance.
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
Medtronic received a report that the doctor gained access with the microcatheter, but could not advance the solitaire to the distal end of the microcatheter.After numerous attempts, they withdrew the solitaire for product complaint submission.The doctor then advanced a new solitaire successfully through the distal end of the same microcatheter and gained reperfusion by removing the clot with the solitaire.The microcatheter was used successfully for the delivery of a second solitaire stent, and thus is not considered a contributor to the product complaint.The device and any accessories were prepared as indicated in the ifu.There was resistance during the procedure during delivery.The vessel was not tortuous.The resistance occurred in the distal section of the catheter.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: as found condition: the solitaire fr4-6-20-10 stent device was returned for analysis still within its introducer sheath, inside a pouch, inside a sealed biohazard bag, and a shipping box.The reported phenom 27 catheter was not returned with the solitaire stent device.Damaged location details: the solitaire fr4-6-20-10 stent¿s finger markers were examined inside the introducer sheath.All finger markers were aligned correctly, and no damage was noted.The introducer sheath was in good condition.The 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.No bends or kinks were noted on the pusher wire, and no other anomalies were found.Testing/analysis: the solitaire fr4-6-20-10 stent device was tested for resistance using an in-house phenom 27 catheter with an inner diameter (id) of 0.027 inches.The stent went through the catheter hub and tip without issues.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: 22438998
• Report Number: 2029214-2025-01537
• Device Sequence Number: 3201235
• Product Code: NRY
• UDI-Device Identifier: 00763000425692
• UDI-Public: (01)00763000425692(17)280107(10)D009277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113455
• 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): 09/02/2025

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: SFR4-6-20-10
• Device Catalogue Number: SFR4-6-20-10
• Device Lot Number: D009277
• 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: 07/05/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 08/07/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/10/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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 Sex: Unknown
• Patient Weight: 65 KG