MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5081-153
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
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
Continuation of d10: product id sfr4-6-40-10 (b791192); product type: date n/a product id 103-0606-200 (b810426); product type: product id sfr4-4-40-10 (b777662); product type: 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.
Event or Problem Description
Additional information received reported an autopsy was not performed.Baseline condition tici 0; no blood flow perfusion.Post-thrombectomy condition: tici 1: partial reperfusion, with limited blood flow restoration to the affected area.Based on the information from physician, there are many factor that can be the cause of the death, not only because the defect of the item.The cause of the solitaire resistance was not definitely known; possibly due to extremely hard clot.Continuous saline flush was administered and maintained as indicated in the instructions for use (ifu).There was no damage observed to the rebar catheter.The solitaire broke in the first pass.The solitaire device was not torqued or repositioned during delivery or retrieval.The patient did not have vessel stenosis proximal to the thrombus site.The microcatheter tip covered the solitaire device proximal marker during the attempted retrieval.During the procedure, the patient remained stable, with vital signs including blood pressure within normal limits.Upon completion of the procedure at approximately 2:00 am, the patient continued to exhibit stable vital signs.In accordance with standard hospital protocol, the patient was transferred to the intensive care unit (icu) for post-procedural recovery.At approximately 10:00 am, the patient was reported to have passed away in the icu due to shock.The solitairex device was utilized during the procedure.The attending physician has confirmed that the patient's death was not attributable to any product defect or damage related to solitairex.The damaged component of the solitairex device was successfully retrieved during the procedure, and no remnants were left in the patient's body.Based on the attending physician¿s assessment and procedural documentation, the patient¿s death was not caused by device malfunction or procedural error.All standard protocols were followed, and the patient was monitored appropriately throughout the process.It was clarified the patient was already unconscious prior to the thrombectomy procedure, although vital signs remained stable.The family requested that the thrombectomy still be performed and agreed to all associated risks, as the patient's condition would have further deteriorated without the procedure.After the thrombectomy procedure was completed, the patient's condition remained the same as it was prior to the operation.The patient did not pass away due to shock, but due to insufficient restoration of blood flow in the distal middle cerebral artery.The attending physician has clinically confirmed that there was no bleeding or vessel rupture resulting from the thrombectomy procedure.What was meant by "shock" was actually "deterioration".
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
Additional information received reported the index procedure was more than 24 hours after the stroke began.The patient was unconscious when brought to the hospital.The clot was hard.Part of the clot was retrieved with the first solitaire (sfr4-6-40-10) which is when the pushwire broke.There was no damage to the microcatheter.The solitaire sfr4-6-40-10 which has broken was successfully retrieved with the solitaire x (sfr4-4-40-10).After that, the physician attempted aspiration of the remaining clot using a non-medtronic system.Despite these interventions, complete revascularization was not achieved.Ancillary devices: penumbra aspiration system.
Additional Manufacturer Narrative
B5 information corrected/updated 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 the index procedure was more than 24 hours after the stroke began.The patient was unconscious when brought to the hospital.The clot was hard.Part of the clot was retrieved with the first solitaire (sfr4-6-40-10) which is when the pushwire broke.There was no damage to the microcatheter.The solitaire sfr4-6-40-10 which has broken was successfully retrieved with the solitaire x (sfr4-4-40-10).After that, the physician attempted aspiration of the remaining clot using a non-medtronic system.Despite these interventions, complete revascularization was not achieved.Correction noted that tici was 1 pre-procedure.It was also noted that tici remained 1 after the procedure.Ancillary devices: penumbra aspiration system.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 22521504
• Report Number: 2029214-2025-01601
• Device Sequence Number: 12765428
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)261104(10)B813957
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K093750
• 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,Followup
• Report Date (Section B): 08/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B813957
• 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; 08/22/2025; 08/25/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/11/2025; 08/25/2025; 08/25/2025
• Date Device Manufactured: 11/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female