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

Model Number	SFR4-4-40-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
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
It was reported that upon trying to retract device after deployment, it "came apart".The pusher wire and all components "unwound".The reported device and any accessory devices were prepared as indicated in the ifu.There were no symptoms.The patient was being treated for ischemic stroke in the m1.1 pass was made with the device.Vessel tortuosity was normal.Ancillary devices included phenom21.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported that the device did not separate.The components of the device unraveled.The cause of the event was not determined.
Additional Manufacturer Narrative
H3: product analysis of sfr4-4-40-10, lotno:b632809 ¿ as found condition: the solitaire x revascularization device was returned for analysis within a shipping box, an opened solitaire x outer carton (b632809), and a plastic bio-pouch.¿ damage location details: no breaks or separations were found with the solitaire x pusher.However, the solitaire x pusher shrink tubing was found damaged at ~5.0cm from the pusher¿s distal end.The solitaire x marker coil was found pulled back from the stent¿s proximal marker for ~1.0cm.The stent was found still attached to the pusher and in good condition.¿ conclusion: based on the device analysis and reported information, the customer¿s report was confirmed as the pusher shrink tubing was found damaged and the marker coil was found pulled back.The damage to the pusher shrink tubing and the marker coil being pulled back could indicate that excessive force was applied during the use of the device.This might have caused the components to "unwind" or appear to come apart.The device might have experienced some form of fatigue or wear during the single pass, especially if there were any unexpected resistances or obstacles within the vessel, even though it was noted to be of normal tortuosity.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: 19981462
• Report Number: 2029214-2024-01419
• Device Sequence Number: 8083382
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: 00763000425678
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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 Expiration Date: 09/27/2026
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B632809
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 09/13/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/28/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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