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

Model Number	SFR4-6-40-10
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was no wire basket on the end of the wire.So no retrieval device.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an ischemic stroke located in the m1.The patient's baseline and postoperative mrs score, nihss score, and tici scores are unknown.It is unknown if intravenous tissue plasminogen activator (tpa) was contraindicated.There were no passes with the device.It was noted the patient's vessel tortuosity was unknown.Stroke onset to reperfusion time is unknown.
Additional Manufacturer Narrative
Product analysis #288424948:equipment used: vis (m-81805), 203cm ruler (m-83360) as found condition: the solitaire x revascularization device was returned for analysis within a shipping box, within an opened solitaire x outer carton (b489618), and within an opened solitaire x inner pouch (b489618) damage location details: the solitaire x pusher was found broken at 183.3cm from the pusher proximal end.When compared to the product drawing, 16.7cm of the distal pusher was found broken and not returned.The pusher shrink tubing was found damaged at the broke location.Dried blood was found within the damaged shrink tubing.Testing/analysis: the broken solitaire x pusher was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via tensile overload.Conclusion: based on the device analysis and reported information, the customer¿s report was confirmed.However, it appears that the solitaire x revascularization device was used and was not an out-of-box failure.Device separation and shrink tubing damage can occur if advanced/retrieved against resistance.As the solitaire x pusher broke due to tensile overload, force was likely applied.However, the cause for the damages could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16912571
• Report Number: 2029214-2023-00784
• Device Sequence Number: 6423616
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: 00763000425739
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 05/11/2023

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: 12/07/2025
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B489618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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 Age: 45 YR
• Patient Sex: Male