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

Model Number	SFR3-6-40-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	05/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the patient died due to cerebral hemorrhage during a solitaire procedure.The patient was undergoing treatment for ischemic cerebral infarction in the internal carotid artery.Two passes had been made with the solitaire device.The patient's vessel tortuosity was strong.It was reported that patient developed cerebral infarction associated with occlusion from the internal carotid artery to the middle cerebral artery (m1, m2) and was transported to the hospital.A solitaire revascularization device was deployed twice in the c2 occ lusion site of the internal carotid artery.Subsequently, an embotrap revascularization device was deployed twice in the internal carotid artery terminal occlusion site, and was deployed twice in the middle cerebral artery branch occlusion site.It was stuck on the distal side when the last thrombus was collected.When the catheter was withdrawn as is, straightening of the blood vessel was observed from the middle cerebral artery m1 to the m2 region, and when the catheter was withdrawn continuously, the stuck was come off.Subsequently, hemorrhaging occurred.Treatment for hemorrhaging is unknown.The final revascularization rate was tici:2b, but the patient developed severe cerebral hemorrhage which caused their death.The physician noted that the patient was old, so the risk of hemorrhaging was high.Furthermore, the patient already had an extensive infarction when the procedure was initiated; it was difficult to perform revascularization if it was not deployed several times using solitaire or embotrap.There was a passive blood vessel (straightening) at the time of final revascularization, which might have triggered cerebral hemorrhage.It was collected quite slowly, but it was trapped on the distal side; when it was pulled, the blood vessel became straightened; that trap came off at some point.It was noted that the usage site of the solitaire was different than where the hemorrhage occurred.

• Brand Name: SOLITAIRE FR3
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13005443
• Report Number: 2029214-2021-01610
• Device Sequence Number: 1816896
• Product Code: NRY
• UDI-Device Identifier: 00847536020559
• UDI-Public: 00847536020559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: SFR3-6-40-10
• Device Catalogue Number: SFR3-6-40-10
• Device Lot Number: A835322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/14/2021
• Date Device Manufactured: 05/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown