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

Model Number	SFR3-4-40-10
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a solitaire stent and marksman catheter used during a procedure in which a fragment which may have been a marker was left inside the patient.The patient was being treated for ischemic cerebral infarction which included tandem lesions of the cca and m1 occlusion.Vessel tortuosity was severe.It was reported that flow restoration had previously failed to be restored from the thrombus of the cca with plasminogen activator (t-pa) therapy so a competitor's stent was placed to open the blood vessel.Once the blood vessel was open, the marksman was able to be delivered to the m1 distal region and the solitaire was deployed to capture the thrombus.The device was pulled halfway back without problems but then the solitaire got caught on the non-medtronic stent that was in place and could not be moved.It was pulled forcibly and was then able to be moved and the solitaire was retrieved.Revascularization was achieved.However, in a post-op ct scan, it was appeared that a fragment remained in the patient that may possibly have been a marker from a solitaire marker or marksman marker.The patient did not have any immediate residual symptoms at the time and possibility of further treatment was not known.

• 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: 10015508
• Report Number: 2029214-2020-00418
• Device Sequence Number: 2078062
• Product Code: NRY
• UDI-Device Identifier: 00847536020535
• UDI-Public: 00847536020535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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: 11/25/2021
• Device Model Number: SFR3-4-40-10
• Device Catalogue Number: SFR3-4-40-10
• Device Lot Number: A939386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2020
• Initial Report FDA Received Date: 04/30/2020
• 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