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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that a thrombectomy was performed in the right m2 vessel.One pass was performed with subject retriever and an aspiration catheter.There was no vessel perforation, vessel dissection or device malfunction during procedure.Physician successfully completed the procedure.Follow up ct scan post procedure showed intracranial and sub arachnoid hemorrhage.Medical intervention/treatment done for the hemorrhage is unknown.Physician suspects that hemorrhage was caused by infarction.No other information is available.
Additional Manufacturer Narrative
A device history record (dhr) could not be reviewed because the lot number remains unknown, however 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.It was reported that after thrombectomy with the subject retriever, the patient showed intracranial hemorrhage (ich) and symptomatic subarachnoid hemorrhage (sah) on follow up.There was no vessel perforation, vessel dissection, or device malfunction during the procedure and there were no issues with delivery/deployment of the subject retriever.In the physician's opinion, the event was caused by hemorrhagic infarction.The cause of the ich and sah on follow up and relation to the subject device could not be definitively determined from this investigation.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 a thrombectomy was performed in the right m2 vessel.One pass was performed with subject retriever and an aspiration catheter.There was no vessel perforation, vessel dissection or device malfunction during procedure.Physician successfully completed the procedure.Follow up ct scan post procedure showed intracranial and sub arachnoid hemorrhage.Medical intervention/treatment done for the hemorrhage is unknown.Physician suspects that hemorrhage was caused by infarction.No other information is available.

• 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: 10731568
• Report Number: 3012931345-2020-00165
• Device Sequence Number: 3111873
• 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?: No
• 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: 10/06/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: 4 MAX CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR