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

Model Number	SFR3-4-20-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The solitaire stent will not be returned for evaluation as 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 a report that a pass was attempted with reported solitaire 4x20 stent but did not re-vascularized the vessel.Attempted a pass with another medtronic stent but still did not re-vascularized the vessel.Then the physicians stented the lesion with a non-medtronic stent.After deployment, the non-medtronic stent clotted off.The physician the attempted to use solitaire 4x20 to open the blocked stent by opening it with the existing stent, but not pulling or pushing the solitaire upon deployment.The solitaire became entangled in the non-medtronic stent and could not be recapture or removed.The solitaire stent was then deployed, and the delivery wire was deliberately torqued until it fractured at the proximal marker leaving the solitaire implanted in the non-medtronic stent.The patient underwent thrombectomy treatment for ischemic stroke in right m1.The characteristics of the clot was atherosclerotic.The vessel was severely tortuous.Integrelin was given to the patient.Regarding patient current medical condition not sure made available.

• 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: 8848679
• Report Number: 2029214-2019-00803
• Device Sequence Number: 11274709
• Product Code: NRY
• UDI-Device Identifier: 00847536029279
• UDI-Public: 00847536029279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/31/2019

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 Model Number: SFR3-4-20-10
• Device Lot Number: A514600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/31/2019
• 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: 65 YR
• Patient Weight: 104