MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the dhr 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 event description indicates 'subarachnoid haemorrhage - small volume of sah' occurred.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.The subject device is unavailable to manufacturer.
Event or Problem Description
During thrombectomy procedure, the subject device retriever was used to remove the proximal face of clot located at the right mca (middle cerebral artery) m1 extending to m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0 and national institute of health stroke scale (nihss) of 18 and mrs (modified rankin score) of 1.It was reported that during procedure, sah (subarachnoid hemorrhage) occurred.There were no serious adverse event or neurological deterioration reported due to the sah and no medical management was administered in response to the patient hemorrhage.The procedure was completed successfully, and the patient¿s neurological assessment showed tici of 3 and nihss of 15 after 24 hours procedure.The patient was discharged approximately 5-7 days post procedure with nihss of 15 and mrs of 4.No other information was provided.
Event or Problem Description
During thrombectomy procedure, the subject device retriever was used to remove the proximal face of clot located at the right mca (middle cerebral artery) m1 extending to m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0 and national institute of health stroke scale (nihss) of 18 and mrs (modified rankin score) of 1.It was reported that during procedure, sah (subarachnoid hemorrhage) occurred.There were no serious adverse event or neurological deterioration reported due to the sah and no medical management was administered in response to the patient hemorrhage.The procedure was completed successfully, and the patient¿s neurological assessment showed tici of 3 and nihss of 15 after 24 hours procedure.The patient was discharged approximately 5-7 days post procedure with nihss of 15 and mrs of 4.No other information was provided.Update information: received on additional on 19-jan-2021 indicated that the patient¿s current condition is ongoing.The stent and patient¿s anatomy were the cause of the subarachnoid hemorrhage.The patient anatomy was noted to be moderate tortuous.There were no difficulties encountered during the procedure that could have contributed to the hemorrhage and the subject device performed as expected during the procedure.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there are controls in the manufacturing process to ensure the product met specifications upon release and there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The event description indicates 'subarachnoid haemorrhage - small volume of sah' occurred.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 3MM 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: 11135885
• Report Number: 3012931345-2021-00006
• Device Sequence Number: 2350107
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133464
• 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): 02/03/2021

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: 04/10/2022
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000043834
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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: AXS CATALYST 7 (STRYKER); AXS INFINITY LONG SHEATH CATHETER (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER); TRANSEND GUIDEWIRE (STRYKER); TREVO PRO 18 (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR