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

Model Number SFR-6-30

Device Problem Separation Failure (2547)

Patient Problem Vascular Dissection (3160)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

This event has been previously reported under manufacturer report # 2029214-2021-00434.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the patient's artery became dissected during a thrombectomy and a solitaire fr could not be detached.The patient was undergoing treatment for a thrombus removal in the patient's right internal carotid artery/middle cerebral artery. patient vessel tortuosity was minimal.The stroke onset to reperfusion time was 4 hours.It was reported that after the thrombus was removed, it was found that the m1 segment was dissected.The stent supporting blood flow was normal, and the blood flow of the retracted stent was blocked, so it was decided to put in solitaire fr 6x30 stent.After placing it, the device couldn¿t be deployed, even after replacing the cable and using a new battery.The solitaire fr was removed and replaced with a 6x30 solitaire ab.According to the previous operation, it was deployed successfully after 40 seconds.The physician had attempted to detach the stent 3 times for 5-15 minutes each attempt.The detachment box and cable were new, and there was no damage noted to the box.The catheter tip was 2-3mm away from the detachment zone which was not against the vessel wall.A 20ml needle was used, and was placed in the muscle next to the puncture point.The detachment box displayed as indicated in the instructions for use (ifu).The pushwire was on a dry clean surface.The black cable was connected to the needle, and the red cable was connected to the pusher wire. the patient did not experience any injury or complications.The devices were prepared according to the ifu.Additional information received clarified that after the thrombus was removed, it was found that the m1 blood vessel was still narrow but not dissected.They continued to open it with the solitaire fr stent and opened it at the position.After the stent was retracted, the blood flow was blocked again, so they decided to deploy the stent.After the stent was placed in a narrow place, it couldn¿t be deployed.They replaced the cable and used a new battery, and it still couldn¿t be deployed, it could only be removed.The solitaire fr was replaced with the solitaire ab stent into it, according to the previous operation, and it was deployed successfully after 40 seconds.

Manufacturer Narrative

H3: analysis of the solitaire fr (lot no.A950544) found no damages or irregularities with the introducer sheath.No damages or irregularities were found with the solitaire fr pusher.The marker coil was found intact and unstretched.No damages were found with the non working (teardrop) length struts, the working length struts, or the finger markers.The finger markers were properly aligned within the introducer sheath.The solitaire fr stent was advanced out of the introducer sheath without resistance encountered.The detachment zone was found intact with no evidence of detachment attempts.Dried blood and fibers were found on the detachment zone.The blood was dissolved, and continuity testing was performed on the stent device.The stent was electrically isolated; the detach wire was not electrically isolated which is normal.These results indicate that the stent should be able to detach normally.An in house solitaire detachment system and cable set was then used to detach the solitaire fr.The stent detached on the first attempt at 1 minute 12 seconds with no issues found.Based on the device analysis and reported information, the customer¿s report of ¿non detachment¿ was confirmed, however the cause could not be determined, and the failure could not be replicated.Furthermore, the solitaire fr revascularization device is not labeled for detachment per ifu.Regardless, in house detachment testing, was successful in detaching the solitaire fr.No defect was found with the returned solitaire fr stent device that would have contributed to the event.H6: method code updated to b01.Result code updated to c19.Conclusion code updated to d14.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 FR
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11936032
• MDR Text Key: 254317569
• Report Number: 2029214-2021-00661
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K113455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: SFR-6-30
• Device Catalogue Number: SFR-6-30
• Device Lot Number: A950544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56