MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that 4 pass was performed using the subject device retriever and aspiration catheter for cardio embolic developed on the left m2.Pre procedure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 1 and mrs (modified rankin score) of 4.The procedure was completed with tici of 2b and mrs of 6.Approximately one day post procedure, the patient ct (computed tomography) scan and mri (magnetic resonance imaging) showed the cerebral hemorrhage (ph-2), symptomatic intracranial hemorrhage and sah (subarachnoid hemorrhage).It is unknown if the hemorrhage was treated.It was reported that the patient passed away fourteen days post procedure and the cause of the death is unknown.No other information was provided.
Event or Problem Description
It was reported that 4 pass was performed using the subject device retriever and aspiration catheter for cardio embolic developed on the left m2.Pre procedure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 1 and mrs (modified rankin score) of 4.The procedure was completed with tici of 2b and mrs of 6.Approximately one day post procedure, the patient ct (computed tomography) scan and mri (magnetic resonance imaging) showed the cerebral hemorrhage (ph-2), symptomatic intracranial hemorrhage and sah (subarachnoid hemorrhage).It is unknown if the hemorrhage was treated.It was reported that the patient passed away fourteen days post procedure and the cause of the death is unknown.No other information was provided.Update information: received additional information on 10-nov-2020 indicated that the patient death was caused by the patient¿s preexisting condition.
Additional Manufacturer Narrative
Section b2 outcomes attributed to ae: updated.Section b5 executive summary - updated.Section h1 type of reportable event: updated.Section f10 health impact code grid : corrected - death has been removed.Although the dhr (device history record ) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information indicates the cause of death and hemorrhage was due to the patient¿s preexisting condition.The reported 'patient intracranial hemorrhage' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.

• Brand Name: TREVO XP PROVUE 4MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10771749
• Report Number: 3012931345-2020-00178
• Device Sequence Number: 4141248
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION CAT 6 (STRYKER).; ASPIRATION CAT 6 (STRYKER)
• Outcome Attributed to Adverse Event: Death; Other