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

Model Number SFR4-4-40-10

Device Problems Break (1069); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Ischemia Stroke (4418)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Medtronic received a report that the solitaire detached unintentionally and remains in the patient.The patient was undergoing surgery for treatment of an ischemic stroke located in m1 segment.It was noted the patient's vessel tortuosity was moderate.Stroke onset to reperfusion time was 3 hours.Intravenous tissue plasminogen activator (tpa) was not contraindicated.There was one pass made with the device.After engagement of the clot in m1, when the physician was trying to retrieve solitaire x, stent was detached and thrombus could not be removed.Mca infarction has occurred.It was reported that the physician was performing a middle cerebral artery (mca) thrombectomy using solitaire x 4x40.First, physician used phenom 21 to deliver solitaire stent to the lesion,m1.After bypassing the clot in m1, using phenom21, stent was fully deployed onto the lesion, where the thrombus is located.2-3 mins later, physician retrieved the stent and proximal part of the stent was detached.It was reported separation occurred.The patient did not have vessel stenosis proximal to the thrombus site.The pushwire was not torqued during the procedure.There was 1 pass made with the stent.There was no friction or difficulty during the procedure.The microcatheter tip did cover the stent proximal marker during retrieval.The stent remained in the patient in the right m1.There is no surgical or medicinal intervention required.The physician did not attempt to detach the stent.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices include a phenom 21 microcatheter.

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.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.

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.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 Description

Additional information received that the patient has minor aphasia post procedure.Nothing could be done to remove the stent, just the stent is still in patient¿s body.The patient will not undergo any further intervention to remove the solitaire.

Manufacturer Narrative

H3: the solitaire x pusher was returned for analysis.The solitaire x pusher was found broken at 192.8cm from the pusher proximal end.Compared to the product drawing, 7.2cm of the solitaire x pusher was found separated and not returned.The solitaire x pusher was sent out for sem failure analysis.Per the sem report, the broken end failed via ductile overload.Based on the device analysis and reported information, the customer¿s ¿separation¿ report was confirmed as the solitaire x pusher was found separated.Pusher separation can occur due to vessel tortuosity, delivery/retrieval friction, a higher number of device passes, guide/balloon catheters or intermediate catheter integrity issues such as kinking within the shaft, not aligning the microcatheter with the proximal end of the solitaire device, or removal of the microcatheter prior to retrieval of the solitaire device with or without clot.The patient's vessel tortuosity was moderate, there was no friction or difficulty during the procedure, there was one pass made with the stent, and the microcatheter tip did cover the stent proximal marker during retrieval.The cause of the pusher separation 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.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
• Type of Device: 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: 18141839
• MDR Text Key: 328187537
• Report Number: 2029214-2023-02220
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K183022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B571629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 03/03/2024
• Supplement Dates FDA Received: 12/27/2023; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other