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

Model Number	SFR3-6-40-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The solitaire stent will not be returned for analysis it will remain in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this solitaire stent entanglement with non-medtronic stent and left in the patient.The patient was undergoing thrombectomy treatment for an ischemic stroke in basilar artery.The vessel was minimal tortuous.It was reported that the patient was having an acute ischemic stroke.Patient also had a stroke the day prior in which two non-medtronic stents had been placed in the basilar artery due to atherosclerotic disease and severe stenosis.On the day of the event, patient was having another ischemic stroke with clot in the basilar artery.Physician attempted to retrieve the clot with the sfr3-6-40-10 in the basilar artery and the solitaire device became stuck on the existing non-medtronic stent and was unable to be resheathed or removed.After multiple attempts at trying to re-sheath and remove the solitaire device it was determined that the push wire on the device needed to be cut and for the solitaire device to remain in the patient.It was determined that the push wire on the stent was to be manually cut at the groin and the remainder of the device to be left in the patient.The push wire did not break or separate on its own.No images available for review.Reported device and any accessory devices prepared as indicated in the ifu.Patient was having an acute ischemic stroke in the basilar artery.Patient had a similar event the previous day and two non-medtronic stents were placed in order to keep the artery open from stenosis.

• 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: 8955431
• Report Number: 2029214-2019-00891
• Device Sequence Number: 2559802
• Product Code: NRY
• UDI-Device Identifier: 00847536034044
• UDI-Public: 00847536034044
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/03/2019

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: 12/09/2020
• Device Model Number: SFR3-6-40-10
• Device Lot Number: A753149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR