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

Model Number SFR4-6-40-10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2022

Event Type  Death  

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

Medtronic received information regarding a solitaire x that separated/detached during a procedure and the patient died post-operatively. it was reported that the patient was undergoing a mechanical thrombectomy procedure to treat ischemic stroke.Tissue plasminogen activation (tpa) was contraindicated.The solitaire x stent retriever and all accessory devices were prepared as indicated in the instructions for use (ifu).The doctor made 1 pass with only aspiration and made 4 additional passes with the solitaire and aspiration.The solitaire neither aggravated nor improved the situation of the stroke.However, on the last pass, the solitaire stent detached from the pushwire and the stent remained in the cerebral artery.Due to the failure of the thrombectomy procedure and contraindication of fibrinolysis, it was felt that little more could be done except some blood pressure management.The carotid artery could not be recanalized.The procedure took place from 1600 to 1800 and the patient died post-operatively at 0200.It was unknown if the device contributed to the patient death or if the death occurred due to the index stroke.

Event Description

Additional information received reported that the thrombectomy took place on (b)(6) 2022 in the afternoon and the patient died on (b)(6) 2022 in the early morning.Initial nihss was not calculated, after symptom onset the patient deteriorated significantly and was intubated.(the patient was hospitalized for endocarditis).The ct scan, priot to the thrombectomy, showed a thrombus in the distal segment of the internal carotid artery and in the m1 segment of the middle artery cerebral artery with a perfusion shift from the territory of the left middle cerebral artery.The initial tici score on diagnostic angiography was '0'.Tici final score was '0' after 4 tries and remained '0' after the fifth after the incident at the end of the procedure.The failure of the recanalization and diffuse left cerebral ischemia in addition to the endocarditis were the main causes of death, however no autopsy was performed to confirm this hypothesis.

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.

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.

Manufacturer Narrative

H3.Product analysis: equipment used: vis (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5).As found condition: the pushwire was returned for analysis within the inner pouch and outer carton; inside of a biohazard bag and a shipping box.There was no solitaire x stent returned with the pushwire as it was remained inside the patient.Visual inspection/damage location details: total length of the returned pushwire was measured ~151.0cm.The pushwire appeared to be broken at 49.0cm from the distal finger marker.Kinks and bends were observed at 2.5cm to 5.6cm from the broken end.The broken end sent out for sem analysis.Testing/analysis: per sem results: the wire failed via ductile overload.Conclusion: based on the reported information and the device analysis, the customer complaint was confirmed as the pushwire was found broken.Per sem results: the wire failed via ductile overload.In addition, the kinks and bends were observed near the broken end.However, the root cause and cause for damages could not be determined.Per the instruction for use: "for vessel safety, do not perform more than three recovery attempts in the same vessel using the solitaire¿ x revascularization device." h6.Coding updated based on analysis results.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: 15528546
• MDR Text Key: 301022280
• Report Number: 2029214-2022-01647
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B361214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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): Death
• Patient Age: 58 YR
• Patient Sex: Male