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

Model Number	SFR4-4-40-10
Medical Device Problem Codes	Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	02/24/2026
Type of Reportable Event	Serious 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
Medtronic received a report that alleges device involvement in a procedure related injury.The patient was undergoing surgery for treatment of a m1 stroke.After the third pass with a ballast, apro 70 medium carrier, and a solitaire 4x40 the physician was removing the apro and the solitaire.The physician noticed a metal wire coming out of ballast.Then the physician removed all of the metal and ballast.During the follow up angiograph it showed a hemorrhage in distal internal carotid artery (ica).The cause is unknown.The representative noted, "from the pictures the apro looks to be in tack with no issues.The ballast looks intact from the outside but the metal wire is coming out of the hub.And there were polymer pieces removed from the ballast after it was removed from the body.".
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 as of right now the cause of the event has not been determined.The consensus from the hospital is that inside polymer of the ballast came off causing it to unravel from the inside.The ica hemorrhage occurred during the procedure, it was noticed after the third pass.When they pulled the solitaire out of the ballast.They noticed a metal coil coming out of the ballast.They pulled the wire and ballast out.Then re imaged the carotid and noticed the hemorrhage.The patient's base line condition was tici 0, and the patient¿s post-thrombectomy condition is currently unknown.It was stated that outside of the hemorrhage and vessel sacrifice to treat the hemorrhage they were not able to successfully treat the patient's stroke.As of now the patient is symptomatic from stroke and it is unknown if the event made symptoms worse or not.The device was prepared as indicated in the ifu.Overall the procedure was unable to remove clot from stroke coiled off the distal ica.
Event or Problem Description
Additional information received reported that the apro catheter was being extracted from the introducer sheath it started to unravel and had plastic coming with it.The events leading up to the procedure incident were as follows: the balt ballast introducer sheath was introduced into the right ica, the apro catheter was introduced through the guide sheath, then the solitaire was introduced into the sheath.The solitaire was unable to be retrieved through the introducer sheath.All items had to be removed together.Upon removal of the items in one unit it was noticed the apro was frayed.The patient suffered damage from the frayed apro and was in critical condition.This contradicts the earlier report that the apro appeared to be intact.
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.

• 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: 24498550
• Report Number: 2029214-2026-00355
• Device Sequence Number: 10115745
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: (01)00763000425678(17)271202(10)D002067
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: D002067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 04/02/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/09/2026
• Date Device Manufactured: 12/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown