MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject device retriever along with other devices were used to remove the proximal face of clot on the right m2 middle cerebral artery (mca).Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction score (tici) of 0, national institute of health stroke scale (nihss) of 25 and mrs (modified rankin score) of 0.During study procedure, the subarachnoid hemorrhage (bleeding) occurred at landing site of the subject device retriever; therefore, 5 coils were used to treat the occlusion of the bleeding arterial site.There were no serious adverse event or neurological deterioration reported to the patient.24 hours post procedure, the patient¿s (tici) of 3 and nihss score of 24.No other information was provided.
Additional Manufacturer Narrative
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.The event description states 'subarachnoid haemorrhage: bleeding at landing site of stentretriever'.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.
Event or Problem Description
It was reported that the subject device retriever along with other devices were used to remove the proximal face of clot on the right m2 middle cerebral artery (mca).Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction score (tici) of 0, national institute of health stroke scale (nihss) of 25 and mrs (modified rankin score) of 0.During study procedure, the subarachnoid hemorrhage (bleeding) occurred at landing site of the subject device retriever; therefore, 5 coils were used to treat the occlusion of the bleeding arterial site.There were no serious adverse event or neurological deterioration reported to the patient.24 hours post procedure, the patient¿s (tici) of 3 and nihss score of 24.No other information was provided.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 10816810
• Report Number: 3012931345-2020-00188
• Device Sequence Number: 11806596
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143077
• 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: 90186
• Device Catalogue Number: 90186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/10/2020
• 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: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); FLOWGATE² BALLOON GUIDE CATHETER (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER); AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); FLOWGATE² BALLOON GUIDE CATHETER (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR