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

Model Number SFR4-6-40-10

Device Problems Break (1069); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problems Stenosis (2263); Thromboembolism (2654); Foreign Body In Patient (2687)

Event Date 06/11/2022

Event Type  Injury  

Event Description

Medtronic received information that a solitaire fr stent had resistance with a phenom21 catheter.The devices were prepared as indicated in the package insert.An attempt was made to deliver the product, but quite a lot of strong resistance was generated from the catheter (c1), and friction was also generated, so phenom21 slipped.The product was removed, after the guidewire was inserted again, the phenom21 crossed the region.Similarly, it was delivered while a strong resistance was felt and deployed.The expansion length was over 20 mm.Start collecting the product by pinching it with cat6 (arts method).The distance between cat6 and solitaire was slightly different, but even though careful collection was performed, an even stronger resistance was generated when the ic-top was reached around 30 mm from the active zone tip of the solitaire.Even if it was tried to collect, the blood vessel will be pulled.It seems that it got stuck while the blood vessel was shrinking.An attempt was made to cover the phenom 21 but it got stuck in the blood vessel and could not be resheath.Afterwards, the collection was continued, but the stent and wire connection part was disconnected.After collecting cat6 and phenom21, the solitaire disconnected part was tried to collect with snare but it could not be collected, so the procedure was completed.The resistance was intraoperative.It occurred during delivery.The blood vessel had strong tortuosity.The resistance was felt in the distal center of the catheter.The vascular stenosis was proximal to the thrombus formation site.The physician did not apply torque to the delivery pusher.1 pass was preformed using the same stent.When the stent was collected the proximal marker of the stent was located within the microcatheter.The stent location was in the proximal m1 location.Surgical or medical intervention was required.A collection using snare was planned, but it could not be collected.The patient was being treated for a ischemic cerebral infaction in the left m1 to m2.Mrs (pre-operative) 4.Mrs (postoperative) 4.Nihss (pre-operative) jss20.Nihss (postoperative) jss30.Tici (pre-operative) 0.Tici (postoperative) 0.The patient was trated with a tpa.1 pass was made with the solitaire device.Parent vessel diameter 2.2 mm.The solitaire remains in the body due to the solitaire disconnection.Thrombosis not recovered, atherosclerotic occlusion, and dissociation was suspected, so it was occluded from the ic-top.

Manufacturer Narrative

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

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

Additional information received reported that the patient has not yet recovered.It was noted that the doctor was suspecting a defect in a hub of solitaire or a defect inside the catheter because there was strong friction and resistance during delivering.

• 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: 14710138
• MDR Text Key: 294660514
• Report Number: 2029214-2022-01009
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/13/2022

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 Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B279826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 07/13/2022
• Date Device Manufactured: 10/11/2021
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male