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	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that for a thrombectomy procedure for right internal carotid terminus and right distal m1, subject retriever was used for one pass, followed by second different size stent retriever, and completed procedure with third stent retriever and aspiration catheter.There was no reported vessel perforation, vessel dissection or device malfunction during procedure.Patient mrs (modified rankin scale) before onset was 0 and pre-procedure aspects (the alberta stroke program early ct) score was 5.Patient pre-procedure thrombolysis in cerebral infarction (tici) score was 0 and final tici was 2b.Pre-procedure nihss (nih stroke scale/score) was noted to be 17 and post nihss was 38.Patient had follow up computed tomography (ct) same day after procedure and showed sich (symptomatic intracranial hemorrhage)-ph2 (parenchymatous hematoma 2).Five days following procedure, patient had passed due to exacerbation of cerebral infarction.Cause of exacerbated cerebral infarction is unknown.No other information provided.
Event or Problem Description
It was reported that for a thrombectomy procedure for right internal carotid terminus and right distal m1, subject retriever was used for one pass, followed by second different size stent retriever, and completed procedure with third stent retriever and aspiration catheter.There was no reported vessel perforation, vessel dissection or device malfunction during procedure.Patient mrs (modified rankin scale) before onset was 0 and pre-procedure aspects (the alberta stroke program early ct) score was 5.Patient pre-procedure thrombolysis in cerebral infarction (tici) score was 0 and final tici was 2b.Pre-procedure nihss (nih stroke scale / score) was noted to be 17 and post nihss was 38.Patient had follow up computed tomography (ct) same day after procedure and showed sich (symptomatic intracranial hemorrhage) ph2 (parenchymatous hematoma 2).Five days following procedure, patient had passed due to exacerbation of cerebral infarction.Cause of exacerbated cerebral infarction is unknown.No other information provided.
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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 'there were no vessel perforation, vessel dissection or device malfunction during procedure.On (b)(6) 2020, follow-up ct after the procedure showed sich (ph-2).On (b)(6) 2020, the patient died of exacerbation of the cerebral infarction'.No additional information was received.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 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: 10880802
• Report Number: 3012931345-2020-00203
• Device Sequence Number: 19584478
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/22/2020

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: 10/23/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: ASPIRATION CATHETER (UNKNOWN).; STENT RETRIEVER (UNKNOWN).; TREVO XP PROVUE RETRIEVER 4MM X 30MM (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR