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

Model Number	SFR3-6-40-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Per the solitaire platinum's instructions for use (ifu): for vessel safety, do not perform more than three recovery attempts in the same vessel using solitaire¿ platinum revascularization devices.For device safety, do not use each solitaire¿ platinum revascularization device for more than two flow restoration recoveries.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the physician made multiple attempts to remove a hard clot, with it stated that on the fourth attempt the solitaire device encountered tension when pulling toward the terminus, and the device detaching as the physician continued to pull.As a result the device was implanted in the ica.The patient was undergoing surgery for treatment of an ischemic stroke in the left ica.The devices were prepared as indicated per the ifu.It was noted that the vessel was not tortuous.There was no stenosis proximal to the thrombus site, and the pushwire was not torqued during the procedure.2 passes were made using the stent.

• 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: 8628969
• Report Number: 2029214-2019-00473
• Device Sequence Number: 19397317
• Product Code: NRY
• UDI-Device Identifier: 00847536034044
• UDI-Public: 00847536034044
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160641
• 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
• Report Date (Section B): 05/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: SFR3-6-40-10
• Device Lot Number: A776372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR