MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number SAB-6-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the patient had a cerebral infarction in the m2 segment of the middle cerebral artery, and the treatment plan was to use a stent to remove the thrombus.The access used 8fguiding and catalyst6 intermediate catheter and delivered the intermediate catheter to the ophthalmic artery segment, and the stent catheter used a micro guide wire to pass through the occlusion site to the distal end of the middle cerebral artery.Selected the model sab-6-30 stent, chose to withdraw the microcatheter in the m2 segment, and deployed the stent.The stent pushing rod was fixed, the microcatheter was retracted to the internal carotid artery to completely deploy the stent, and the stent was fully expanded after resting for 5 minutes.After 5 minutes, when pulling the pushing rod of the stent, it was found that the position of the stent in the body had not changed, and the same was true when pushing it forward.When the pushing rod was withdrawn, it was found that the stent had been detached in the body.The operator said that the sab-6-30 stent had quality problem.Marker band separation occurred.The stent was pulled back and detached for no reason.There was no resistance encountered.The reported device and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a m2 ischemic stroke.Iv tpa was not contraindicated.There was 1 pass with the device.It was noted the patient's vessel tortuosity was moderate.Stroke onset to reperfusion time was 4 hours.Additional information received reported that two passes were made with the solitaire prior to the separation.There was no resistance or torque encountered during device delivery or retrieval.The patient did not have vessel stenosis proximal to the thrombus site.The microcatheter tip did not cover the solitaire device proximal marker during the attempted retrieval.The device was in the m2 segment of the middle cerebral artery.No further intervention was schedule.

Manufacturer Narrative

Product analysis #(b)(4): equipment used: vis (m-81805), 203cm ruler (m-83361).Document used: n/a as found condition (condition of returned device): the solitaire ab revascularization device was returned for analysis within a shipping box; within a sealed biohazard-pouch; within an opened solitaire ab inner pouch and within a dispenser track.The catheter used during the event was not returned for analysis.Visual inspection/damage location details: the stent was found to be not attached to the pushwire.No bends or kinks were found with the solitaire pushwire.The solitaire ab stent was found to be separated at the proximal marker band.The distal glue dome was found to be damaged.The marker coil was found to be intact.The solitaire stent was not returned.No other anomalies were observed.Testing/analysis (including sem reports): the proximal marker was placed in acetone to remove glue dome.The marker band was then removed from acetone and dissected (cut) longitudinally.The broken non-working length strut was found to be broken within marker band.Conclusion: based on the device analysis ¿marker separation from stent¿ was confirmed as the stent was found to be separated.The returned stent device was found to be separated from the pushwire.It is not known when the solitaire ab stent device became separated from the pushwire.Based on the condition of the returned solitaire ab stent it appears to have separated due to resistance.However, the solitaire stent was not returned for analysis; therefore, any contributing factors from the stent could not be assessed and the cause for the separation could not be determined.Based on the device analysis ¿premature detachment¿ was unable to be confirmed as the stent was found to be broken and not detached.The root cause for the reported event could not be determined.((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 AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 16564948
• MDR Text Key: 312026431
• Report Number: 2029214-2023-00494
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAB-6-30
• Device Catalogue Number: SAB-6-30
• Device Lot Number: B417744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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