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

Model Number SFR4-6-40-10

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

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

Event Date 06/04/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the solitaire experienced resistance and separated during retrieval.The patient was undergoing treatment for an ischemic stroke located in the basilar region.Three passes were made with the device.The patient's vessel tortuosity was moderate.It was reported that during retrieval into the zoom catheter the solitaire device detached at the fluoro marker on the third pass.There had been resisting during delivery, and the patient's vessel was moderately tortuous.The resistance was in the middle of the catheter.There was no vessel stenosis proximal to the thrombus site, and the pushwire was not torqued during the procedure.The microcatheter tip did not cover the stent proximal marker during retrieval.A snare was used to remove the solitaire.No detachment attempts had been made. the devices were prepared according to the instructions for use (ifu).Ancillary devices include an infinity long sheath, phenom 21 microcatheter, and zoom distal access catheter.

Manufacturer Narrative

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

Manufacturer Narrative

H3: the solitaire x pushwire and zoom distal access (non-medtronic) catheter were returned for analysis.The phenom 21 micro catheter was not returned for analysis.Therefore, any contributing factors could not be assessed.The phenom-021 micro catheter has a labeled id (inner diameter) of 0.021¿.Per the solitaire x ifu (instructions for use), the minimum catheter id required is 0.021¿.Therefore, the phenom-021 micro catheter was found to be compatible for use with the solitaire x revascularization device.The solitaire x pushwire was found to be broken at ~189.0cm from the proximal end.The solitaire x pushwire proximal segment was found to be bent at ~2.1cm from broken end.The solitaire x pusher was found broken ~12.0cm from the stent attachment zone/proximal marker.When compared to the product drawing it appears the entire solitaire x pushwire was returned.The stent attachment zone was found in good condition the solitaire x stent non-working (tear drop) and working length struts were found in good condition.No damages were found with the zoom distal access catheter.The zoom distal access catheter was flushed with water and water exited out of the distal tip.An in-house mandrel was inserted through the zoom catheter and the solitaire x stent was pushed out of the distal tip.No other anomalies were observed.The broken solitaire x pushwire was sent out for (scanning electron micrographic) failure analysis.Per the sem result, ¿the wire failed via ductile overload¿.Due to its damaged condition the solitaire x could not be used for testing with an in-house micro catheter.The zoom catheter total length was measured to be ~136.8cm and the id was measured to be 0.078¿.Per the solitaire x ifu (instructions for use), for a guide catheter a minimum inside diameter 0.061¿¿ is recommended.Therefore, the zoom catheter was found to be compatible for use with the solitaire x device.Based on the device analysis and reported information, the customer¿s report of ¿separation¿ and ¿resistance¿ were confirmed.The solitaire x pusher can become damaged (bent) if advanced against resistance.As the sem result indicated the wire failed via ductile overload it is likely the pusher became bent during delivery against resistance subsequently breaking during retrieval.Resistance can be caused by compatibility, lack of continuous flush or extremely tortuous anatomy.The vessel tortuosity was ¿moderate¿ and the phenom-021 micro catheter and zoom catheter were found to be compatible for use with the solitaire x stent device.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 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: 14626607
• MDR Text Key: 301239611
• Report Number: 2029214-2022-00957
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 64 YR
• Patient Sex: Male