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); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Stroke/CVA (1770); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the solitaire stent broke/fractured off in the distal middle cerebral artery.
Additional Manufacturer Narrative
H3: the model and lot numbers were not provided for the marksman catheter; therefore, compatibility could not be assessed.The solitaire fr revascularization device was returned without its introducer sheath.No bends or kinks were found with the pushwire.No bends or kinks were found with the marker coil.The solitaire device was found to be returned without the stent.The detach wire broken end was unable to be seen from the distal end of the marker coil.The length from the buffer weld to the distal end of the marker coil was measured to be 3.1cm.The outer shrink tubing and marker coil were removed.The detach wire was found to be broken within the marker coil at 3.0mm from the buffer weld indicating that the stent detached at the distal end of the marker coil.No corrosion was found on the broken end of the detach wire.The solitaire fr stent was sent out for sem (scanning electron microscopy) analysis for failure analysis of the detach wire.Per the sem analysis report, the fracture occurred within a flattened surface area.The wire failed via shear overload.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance during retrieval¿ could not be confirmed as the stent was found separated from the pushwire.Therefore, the device could not be used for resistance testing.Resistance can be caused by compatibility, lack of continuous flush or extremely tortuous anatomy.Based on the device analysis and reported information, the customer¿s report of ¿separation¿ was confirmed as the stent was found separated from the pushwire.User errors such as connecting the cables incorrectly, not using a new battery, placing the needle in fat cells, not exposing the detachment zone to blood flow or pulling the microcatheter back too far, and not maintaining saline drip through microcatheter could contribute to the event.Additionally, if not enough blood thinner is used, clots can form on the detachment zone.These user errors can happen even if the device is working correctly.In this event, it is likely that blood got onto the detach wire under the ptfe shrink tubing and the marker coil contributing to the non-detachment issue.This made the detach wire slowly corrode from inside and slowed down the detachment time.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 from a healthcare provider (hcp), via a manufacturing representative (rep), indicated a marksman and headliner wire were used with the solitaire.The device was delivered into the middle cerebral artery (mca), past the m1, and through the clot without difficulty.On the second pass, he got hung up once past the occlusion and the distal end of the solitaire device was compressed and hung up.It was thought it may have had something to do with the patient having had a tavr about six months ago, and maybe a hard calcified rock had dropped and caused the solitaire to get hung up.It was thought the device broke off about 3-4 cm from the proximal end of the stent.The physician tried to retrieve the solitaire with snares for a couple hours but could not.The solitaire was left in the patient.There was no medical or surgical intervention taken or planned.According to the physician, the patient was no worse off than when they originally came in as of the last they had heard: she had a right brain stroke.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6: upon further review, patient code e0133 does not apply.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.

• Brand Name: SOLITAIRE FR4
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11294767
• Report Number: 2029214-2021-00151
• Device Sequence Number: 12001627
• Product Code: NRY
• UDI-Device Identifier: 00847536034730
• UDI-Public: 00847536034730
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/09/2021

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 Expiration Date: 06/30/2023
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B048678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 05/20/2021; 07/09/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/25/2021; 05/21/2021; 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other