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

Model Number	SFR4-6-40-10
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the solitaire device separated.The patient was undergoing treatment for a mechanical thrombectomy of the left ica/mca in a symptomatic acute ischemic stroke patient.The occlusion was in the proximal left m1 segment of the mca.The patient had moderate tortuosity.It was reported that the solitaire was deployed across the clot/stenosis as usual.After a 5-minute wait, the doctor attempted to retrieve (pull back) the solitaire and upon pull back the solitaire distal stent portion separated from the delivery wire.Ancillary devices include a neuronmax 90cm sheath, ace 68 aspiration catheter, and velocity microcatheter.
Additional Manufacturer Narrative
B5.Updated with additional information received.H6.Coding updated based on additional information received.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Event or Problem Description
Additional information received reported the separation occurred during the second or third pass.There was resistance felt during retrieval of the solitaire.The device was not torqued or repositioned.Post-operatively, the physician did think there may have been some stenosis proximal to the thrombus that could have contributed to the event.The microcatheter tip did not cover the solitaire proximal marker during retrieval.There was nothing remarkable about the condition of the clot.The device was discarded by the customer.

• 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: 11400134
• Report Number: 2029214-2021-00228
• Device Sequence Number: 17030468
• Product Code: NRY
• UDI-Device Identifier: 00847536034730
• UDI-Public: 00847536034730
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/01/2021

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: 07/30/2023
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B066330
• 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: 02/21/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 12/01/2021
• Date Device Manufactured: 08/07/2020
• 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: 78 YR
• Patient Sex: Male