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 Codes	Embolus (1830); Intracranial Hemorrhage (1891); Vascular Dissection (3160); Embolism/Embolus (4438)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
During thrombectomy procedure, the first pass was performed with the subject device retriever on the left ica (internal carotid artery) terminus.Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 21 and mrs (modified rankin score) of 0.The pta (percutaneous transluminal angioplasty) and stenting were performed for left m1 proximal not for embolization to new territory (ent) even though the occurrence of ent was observed but was denied by the procedure.It was reported that there was vessel dissection occurred during procedure.Follow-up with ct (computed tomography) scan and mri (magnetic resonance imaging) within 24 hours after the procedure showed symptomatic intracranial hemorrhage sich (hi-2) with nihss of 21.It was unknown what medical treatment was administered to treat the patient¿s sich.The patient was discharged approximately 33 days post procedure with modified ranquin scale (mrs) of 5 and tici score of 3.According to the physician, the event vessel dissection related to subject device retriever.No further information was available.
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 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.It was reported that vessel dissection occurred during the procedure and follow-up with ct and mri within 24 hours post-procedure showed sich (symptomatic intracranial hemorrhage).It was unknown what medical treatment was administered to treat the sich.Additional information provided by the customer indicated that the retriever was confirmed to be in good condition prior to use and performed as intended.Based on the information provided, the causal relationship between the trevo and the reported adverse events is unknown.The reported 'patient embolus', 'patient vessel dissection', and 'patient intracranial hemorrhage' are known and anticipated complications to these types of procedures and patient condition and are 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
During thrombectomy procedure, the first pass was performed with the subject device retriever on the left ica (internal carotid artery) terminus.Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 21 and mrs (modified rankin score) of 0.The pta (percutaneous transluminal angioplasty) and stenting were performed for left m1 proximal not for embolization to new territory (ent) even though the occurrence of ent was observed but was denied by the procedure.It was reported that there was vessel dissection occurred during procedure.Follow-up with ct (computed tomography) scan and mri (magnetic resonance imaging) within 24 hours after the procedure showed symptomatic intracranial hemorrhage sich (hi-2) with nihss of 21.It was unknown what medical treatment was administered to treat the patient¿s sich.The patient was discharged approximately 33 days post procedure with modified ranquin scale (mrs) of 5 and tici score of 3.According to the physician, the event vessel dissection related to subject device retriever.No further information was available update information: received additional information on 8/21/2020 indicated that the patient modified ranquin scale (mrs) of 3 on (b)(6) 2020.

• 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: 10359327
• Report Number: 3012931345-2020-00113
• Device Sequence Number: 2408794
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• 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): 10/22/2020

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?: 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: 07/14/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 45 YR