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 Codes	Intracranial Hemorrhage (1891); Embolism/Embolus (4438)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
During thrombectomy procedure, the subject retriever was used to remove clot from the right mca m1 portion on (b)(6) 2020.After the 1st pass, embolization to new territory (ent) occurred in right a2 segment, then an additional pass was performed to remove m2 clot.Thrombectomy was performed to treat the distal new territory embolus (ent).Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 17 and mrs (modified rankin score) of 0.According to the surgeon, vessel preformation occurred during the procedure but was not due to stryker retriever.24 hours post procedure computer tomography (ct) confirmed, intracranial hemorrhage (ich) was observed.It is unknown if the ich was treated.No additional information was received.Post procedure, the patient neurological assessment showed that the thrombolysis in cerebral infarction (tici) reperfusion grade was 2b, national institute of health stroke scale (nihss) of 21 and mrs (modified rankin score) of 5, three days post procedure.
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.Visual and functional testing could not be performed since the device was not returned for investigation.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.As per the additional information there was no malfunction reported to subject trevo xp provue retriever during the procedure.The reported issues patient embolus 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 subject retriever was used to remove clot from the right mca m1 portion on (b)(6) 2020.After the 1st pass, embolization to new territory (ent) occurred in right a2 segment, then an additional pass was performed to remove m2 clot.Thrombectomy was performed to treat the distal new territory embolus (ent).Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 17 and mrs (modified rankin score) of 0.According to the surgeon, vessel preformation occurred during the procedure but was not due to stryker retriever.24 hours post procedure computer tomography (ct) confirmed, intracranial hemorrhage (ich) was observed.It is unknown if the ich was treated.No additional information was received.Post procedure, the patient neurological assessment showed that the thrombolysis in cerebral infarction (tici) reperfusion grade was 2b, national institute of health stroke scale (nihss) of 21 and mrs (modified rankin score) of 5, three days post procedure.

• 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: 10584291
• Report Number: 3012931345-2020-00147
• Device Sequence Number: 14158653
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/04/2020

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: 90183
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: REACT-71 CATHETER (MEDTRONIC); REACT-71 CATHETER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR