MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
During the procedure for thromectomy for right m1 distal was performed on (b)(6) 2020.Prior to procedure patient modified rankin scale (mrs) before onset was 0, thrombolysis in cerebral infarction (tici) score was 0 and nih stroke scale (nihss) was 20.After one pass was preformed final tici score was 2b and post procedure nihss was 12.The physician did not realize the vessel perforation and dissection at the time of finishing the procedure.Intracerebral hemorrhage (ich) type ph1 was observed in ct and mri follow-up after the procedure on (b)(6), then protamine and transamin was administered to the patient and hemostasis was observed.It was noted that vessel perforation and vessel dissection was in relation to the difficult removal of the subject retriever during the procedure.On (b)(6), patient mrs was 4 at time of discharge.
Event or Problem Description
During the procedure for thromectomy for right m1 distal was performed on (b)(6) 2020.Prior to procedure patient modified rankin scale (mrs) before onset was 0, thrombolysis in cerebral infarction (tici) score was 0 and nih stroke scale (nihss) was 20.After one pass was preformed final tici score was 2b and post procedure nihss was 12.The physician did not realize the vessel perforation and dissection at the time of finishing the procedure.Intracerebral hemorrhage (ich) type ph1 was observed in ct and mri follow-up after the procedure on june 17th, then protamine and transamin was administered to the patient and hemostasis was observed.It was noted that vessel perforation and vessel dissection was in relation to the difficult removal of the subject retriever during the procedure.On july 27th, patient mrs was 4 at time of discharge.
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.Information indicates the anatomy was severely tortuous.It is most likely that anatomical factors encountered during the procedure contributed to the reported event.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undetermined will be assigned to the difficult/unable to withdraw retriever.The reported patient vessel perforation, 'patient vessel dissection' and 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 these reported defects.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• 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: 10723011
• Report Number: 3012931345-2020-00161
• Device Sequence Number: 3180075
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150616
• 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): 12/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: TREVO 18 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR