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

Model Number	SFR3-4-40-10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no device malfunction was reported against the solitaire fr3 was found to be broken at, from proximal end.No issues were found with the marker coil.Visual inspection showed no irregularities outside of the detachment zone.The stent non-working, middle working length and working length struts were in good condition.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that a foreign material was observed in angiography.The patient was undergoing surgery for treatment of ischemic cerebral infarction of the right m1.It was noted the patient's vessel tortuosity was severe, tissue plasminogen activator (tpa) was not performed, and time to recanalization was about 1.5 hours.It was reported that the m1 thrombus was retrieved by the combined technique with the react catheter and solitaire.The thrombus was captured and retrieved with the solitaire.Afterwards, angiography showed something like a foreign material around the m2 or m3 region.It was unknown whether it was due to the retention of contrast agent or part of the device.Comparing the retrieved devices with the demo products, there were no abnormalities in the appearance of the solitaire, react 71, or phenom 27.The foreign material was not retrieved and remained without any actions.A request for inspection results to confirm whether the foreign material was part of the device by domestic microscopy.Ancillary devices include a 9f optimo, phenom 27, chikai guidewire, react 71 catheter.Additional information received reported that the patient did not experience any injury or adverse event.It was unknown what the foreign material was, and it has since disappeared.

• 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: 11062070
• Report Number: 2029214-2020-01361
• Device Sequence Number: 19552168
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 12/17/2021
• Device Model Number: SFR3-4-40-10
• Device Catalogue Number: SFR3-4-40-10
• Device Lot Number: A950790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1