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

Model Number SFR-6-30

Device Problem Break (1069)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a solitaire pushwire that broke.The patient was undergoing a mechanical thrombectomy (mt) procedure to treat ischemic stoke.The infarction was located in the left internal carotid artery and middle cerebral artery.Baseline mrs was 0, nihss was 10, and tici was 0.Vessel tortuosity was severe.It was reported that all devices were prepared as indicated in the instructions for use (ifu).One pass was made with the solitaire during the procedure and the device was found to be broken.The pushwire broke in the middle which in the react-71 catheter.A loach guide wire was used in the react-71 catheter to ensure all broken pieces were retrieved.It was noted the pushwire was not torqued during the procedure.There was no noted resistance encountered during the procedure.The solitaire fr was then replaced with a solitaire ab to complete the procedure.Tici "level 1" was achieved.The patient's post-procedure nihss was 14.

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.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.

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 had vessel stenosis proximal to the thrombus site.The microcatheter tip covered the solitaire device proximal marker during the attempted retrieval.It was noted that the clot was black and hard.

Manufacturer Narrative

Product analysis: as found condition: the solitaire fr stent was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch and within a plastic glove.The solitaire fr pusher was not returned with the stent.Visual inspection/damage location details: the solitaire fr stent was found separated from the pusher at the proximal marker.The solitaire fr stent non-working (tear drop), working length struts, and finger markers were found in good condition.Testing/analysis: the solitaire fr stent was sent out for sem testing.The proximal marker was removed.The stent keyway fingers were found to be intact and still in good condition.The pushwire and ball were not found within the proximal marker.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was confirmed.The solitaire fr stent device appeared to have separated due to a ball slip tensile failure.The solitaire fr pusher was not returned; therefore, analysis could not be performed and conformance to specification could not be assessed.There is an indication that the failure could potentially be related to a manufacturing issue and a dhr review will be performed.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
• 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: 14744699
• MDR Text Key: 301547886
• Report Number: 2029214-2022-01028
• 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,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2023
• Device Model Number: SFR-6-30
• Device Catalogue Number: SFR-6-30
• Device Lot Number: B288984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 60 KG