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 Codes	Death (1802); Intracranial Hemorrhage (1891)
Date of Event	01/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during thrombectomy for cardio embolic of left internal carotid artery(ica), terminus bifurcation was done with the subject retriever and aspiration catheter and successful recanalization was confirmed during the procedure.A few days later, symptomatic intracranial hemorrhage was confirmed in the patient and later the patient passed away.In the physician's opinion, subject retriever performed as intended during the procedure, the cause for the intracranial hemorrhage was bleeding due to the opening of the infarcted area, and the cause of the patient death was worsening of primary disease.No further information is available.
Event or Problem Description
It was reported that during thrombectomy for cardio embolic of left internal carotid artery(ica), terminus bifurcation was done with the subject retriever and aspiration catheter and successful recanalization was confirmed during the procedure.A few days later, symptomatic intracranial hemorrhage was confirmed in the patient and later the patient passed away.In the physician's opinion, subject retriever performed as intended during the procedure, the cause for the intracranial hemorrhage was bleeding due to the opening of the infarcted area, and the cause of the patient death was worsening of primary disease.No further information is available.
Additional Manufacturer Narrative
D4 expiration date - added h3 device evaluated by mfg - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual and function analysis were not performed.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.Additional information indicated that the reported event occurred due to worsening of the primary disease.Based on available information, the reported "patient intracranial hemorrhage" and "patient death" 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, a probable cause of anticipated procedural complication will be assigned to the reported issue.

• 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: 9781395
• Report Number: 3012931345-2020-00034
• Device Sequence Number: 504175
• 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): 03/11/2020

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: 08/20/2020
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000013521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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: AXS CATALYST 6 DISTAL ACCESS CATHETER(STRYKER); AXS CATALYST 6 DISTAL ACCESS CATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 82 YR