MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-4-40-10
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solitaire device has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of solitaire pushwire detachment.The patient was undergoing treatment of an ischemic stroke in the left superior division m2.The patient had a moderate vessel tortuosity.Stroke onset to reperfusion time was 4 hours.It was reported that during the procedure, a solitaire was used.The device would not track beyond the cavernous segment and was removed with the intermediate catheter.After removal, the device was found to be frayed upon inspection.There was also a pushwire break/separation, with it confirmed that the pushwire was not torqued during the procedure.All broken segments were able to be removed from the patient.There were no related patient symptoms.The devices were not prepared per the ifu as the microcatheter was removed over the wire.Mrs baseline and procedure was 4, tici score baseline was 0 and 3 post procedure there were no reports of patient injury in association with this event.
Additional Manufacturer Narrative
The solitaire platinum revascularization device was returned without its introducer sheath.No bends or kinks were found with the solitaire platinum pushwire.The solitaire platinum pushwire ptfe shrink tubing was found damaged (peeling) from ~7.5cm to ~5.5cm from the stent proximal marker.No bends or kinks were found with the solitaire platinum marker coil.No irregularities were found with the solitaire platinum proximal marker/attachment zone.The solitaire platinum stent non-working (tear drop) and working length struts were in good condition.No breaks or separations were found with the returned solitaire platinum revascularization device.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance during retrieval¿ could not be confirmed.It was reported the micro catheter was removed prior to retrieval of the solitaire platinum revascularization device.As the micro catheter is to provide support to the solitaire platinum revascularization device during recovery it is likely use context contributed to the resistance during retrieval issue.In addition, it is possible the patient¿s ¿moderate¿ vessel tortuosity contributed to the resistance issue.It is likely the resistance during retrieval caused the solitaire platinum pushwire ptfe shrink tubing to become damaged as the user continued to retrieve the device against resistance.Regarding the customer¿s report of ¿pushwire b reak/separation¿ the issue could not be confirmed as no breaks or separations were found with the returne d solitaire platinum revascularization 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 FR3
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8506702
• Report Number: 2029214-2019-00342
• Device Sequence Number: 19239658
• Product Code: NRY
• UDI-Device Identifier: 00847536020535
• UDI-Public: 00847536020535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: SFR3-4-40-10
• Device Catalogue Number: SFR3-4-40-10
• Device Lot Number: A676643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR