MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 0.14 GUIDEWIRES; WIRE, GUIDE, CATHETER

Model Number	103-0606-200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Ischemia Stroke (4418); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Information received indicated pli30 and pli40 are no longer reportable.Since a regulatory report has been sent gch functionality does not allow the complaint flag to be changed to no.Should further information make the event reportable again the event will be reopened and a regulatory report will be sent.See section h.6.For corrected codes.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
Continuation of d10: product id sfr4-6-40-10 (b791192); implant date n/a; explant date n/a product id 105-5081-153 (b813957); implant date n/a; explant date n/a product id sfr4-4-40-10 (b777662); implant date n/a; explant date n/a 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 information regarding a solitaire x stent retriever (sfr4-6-40-10, lot: b791192) that broke during a procedure.It was reported that patient was undergoing a mechanical thrombectomy procedure to treat a non-hemorrhagic stroke.The solitaire and all accessory devices were prepared as indicated in the instructions for use (ifu).The solitaire was deployed for clot retrieval.However, during retrieval, there was resistance in the distal end of the catheter (rebar, 105-5081-153, lot: b813957) and the solitaire broke and remained in the clot.The surgeon used another solitaire x (sfr4-4-40-10, lot: b777662) to retrieve the broken solitaire along with the clot.It appears the broken device was successfully retrieved.However, it was noted that the patient ultimately had an outcome of death.

• Brand Name: 0.14 GUIDEWIRES
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 22521522
• Report Number: 2029214-2025-01602
• Device Sequence Number: 8058475
• Product Code: DQX
• UDI-Device Identifier: 00763000338275
• UDI-Public: (01)00763000338275(17)271028(10)B810426
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K113454
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 103-0606-200
• Device Catalogue Number: 103-0606-200
• Device Lot Number: B810426
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 10/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female