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 Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  Injury  

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 a report that the surgeon used solitaire ab for assistance when performing ophthalmic artery aneurysm embolization.Finally, when connecting the 9v dry battery with the red and black cables to detach, it could not be detached.Tried twisting the push rod at the tail end of the stent, but still could not be detached, and finally gave up.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Additional information was received that clarified that the stent used was the solitaire fr.The surgeon used the red and black wire and connected it to a 9v battery.After about 40 seconds, there was no detachment.Then he tried to twist the push rod at the end of the stent to achieve detachment, but was unsuccessful.The patient's heart rate changed significantly, so he gave up the detachment.The physician did not feel any resistance while delivering the stent.The stent was deployed for 2 minutes prior to detachment.The physician attempted to detach the stent with the detachment box 2 times for 2 minutes per attempt.The detachment box and cable were re-used.The detachment box was displayed as indicated per the ifu.Cable polarity was set up as indicated in the ifu.The needle was placed in the shoulder muscle layer.The black cable was connected to the needle, the red cable to the pusher wire, and the pushwire was on a dry clean surface.The stent was not in a bend.There were no visible damaged on the detachment cable.

Manufacturer Narrative

H3: product analysis of sfr-6-30, lot no: b474567 found.The finger marker struts aligned within the introducer sheath.No damages were found with the introducer sheath.No bends or kinks were found with the solitaire fr pusher.No damages were found with the solitaire fr pusher marker coil.The stent was found to be still attached to the pusher.The stent¿s non-working tear drop, middle and working length struts were in good condition.No other anomalies were observed.Continuity testing was performed on the returned solitaire 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.The detachment test was then performed using an in-house solitaire detachment system and cable set.The stent detachment occurred at 1 minute and 29 seconds.Based on the device analysis and reported information, the customer¿s report of ¿non-detachment¿ was confirmed as the stent was found still attached to the pusher.¿non-detachment¿ can occur if the cables are connected incorrectly, not using a new battery, placing the needle in fat cells, not exposing the detachment zone to blood flow or pulling the microcatheter back too far, not maintaining saline drip through the microcatheter and not placing the pusher on a dry and clean surface.Additionally, if not enough blood thinner is used, clots can form in the detachment zone.These user errors can happen even if the device is working correctly.It was reported the physician connected the cables correctly, the needle was placed in the shoulder muscle layer, and the pusher was placed on a dry and clean surface.The root cause for the reported event could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received stating that the surgery was completed using another brand of intracranial stent.The procedure was not abandoned or delayed.There were no actions taken to resolve the patient's heart rate change.The heart rate change was not due to the medtronic device/therapy.This event is no longer a reportable event.Mdr decision updated to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.

• Brand Name: SOLITAIRE FR
• 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: 18768973
• MDR Text Key: 336124876
• Report Number: 2029214-2024-00329
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113455
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR-6-30
• Device Catalogue Number: SFR-6-30
• Device Lot Number: B474567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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): Other