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

Model Number SFR4-4-40-10

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

Patient Problems Rupture (2208); Vascular Dissection (3160)

Event Date 02/03/2022

Event Type  Death  

Event Description

Medtronic received information regarding a patient death after a solitaire sfr4 stent detached from a pusher wire during retrieval and was lodged in the vessel.Multiple attempts were made to retrieve the stent and the stent was retrieved successfully but a tear in the vessel ensued.The patient became deceased.After using a different 6x40 stent on first pass it was successfully positioned and then switched to 4x40 stent in question and the event happened when retrieving stent into a (b)(4) catheter. ancillary devices: (b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a patient death after a solitaire sfr4 stent detached from a pusher wire during retrieval and was lodged in the vessel.Multiple attempts were made to retrieve the stent and the stent was retrieved successfully but a tear in the vessel ensued.The patient became deceased.After using a different 6x40 stent on first pass it was successfully positioned and then switched to 4x40 stent in question and the event happened when retrieving stent into a react68 catheter. ancillary devices: react68.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2022 e1,1 (rep, hcp, medwatch): additional information received reported the lesion characteristics were internal carotid artery (ica) and m1 complete occlusion.Vessel tortuosity was moderate.The patient pasted away immediate post care.The death was related to a medtronic device.The cause of death was a vessel bleed.The procedure was stopped and all devices removed.The patient was hospitalized prior to passing of heavy drug use and cardiac issues.The device was being used to restore blood flow by removing thrombus for the treatment of acute ischemic stroke in a patient with a large vessel occlusion who first received intravenous tissue plasminogen activator (iv t-pa).The solitaire fractured form the delivery wire while the physician was attempting to retrieve the device of the fourth attempt at thrombectomy.Device failed e.G.Broke.The physician was able to retrieve the fractured device piece with a 7mm snare.Immediate angiography showed a catastrophic rupture of the let middle cerebral artery.Open intervention could not be done because the patient had received iv t-pa.The patient was taken to cardiovascular intensive care unit and intubated on cardene drip.

Manufacturer Narrative

Event related to medwatch (b)(4).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: 13517691
• MDR Text Key: 285500554
• Report Number: 2029214-2022-00206
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: 00763000425678
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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 Expiration Date: 03/18/2024
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B180491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/08/2022
• Date Device Manufactured: 03/24/2021
• 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: 36 YR
• Patient Sex: Male