MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
During treatment of cardiogenic cerebral embolism, the subject retriever and aspiration catheter were used to remove the thrombosis.The patient mrs (modified rankin scale) pre procedure of 2 and immediately after pass mtici (thrombolysis in cerebral infarction) score of 1 was achieved.It was reported that symptomatic intracranial hemorrhage occurred after procedure and was assessed having a mrs of 5.The patient¿s current condition is unknown.No further information is available.
Additional Manufacturer Narrative
The device history record (dhr) for the device implicated in this complaint has been reviewed for manufacturing issues that could potentially relate to the as reported defect.The reported defect was not confirmed, and it cannot be confirmed that the device met specification as the device 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 reported issue 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, a probable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
During treatment of cardiogenic cerebral embolism, the subject retriever and aspiration catheter were used to remove the thrombosis.The patient mrs (modified rankin scale) pre procedure of 2 and immediately after pass mtici (thrombolysis in cerebral infarction) score of 1 was achieved.It was reported that symptomatic intracranial hemorrhage occurred after procedure and was assessed having a mrs of 5.The patient¿s current condition is unknown.No further information is available.

• Brand Name: TREVO XP PROVUE 4MM 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: 10059743
• Report Number: 3012931345-2020-00074
• Device Sequence Number: 11458990
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• PMA/510(K) Number: K132641
• 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): 08/10/2020

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 Expiration Date: 01/01/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000020367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: SOFIA FLOW PLUS ASPIRATION CATHETER(MICROVENTION)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR