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	Perforation of Vessels (2135)
Date of Event	01/05/2020
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 during the procedure for cardio embolic developed on the left cervical-ica (internal carotid artery) on (b)(6) 2020, three passes were performed using subject retriever along with microcathter.Physician then noted that there was vessel perforation with a possible casual relationship occurred during procedure.Before the procedure patient mtici grade was 0 and immediately after mtici grade was 2a.Patient mrs grade before procedure was 0 and immediately after mrs was grade 4.No further information provided.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H4 manufacturing date ¿ added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.The reported patient vessel perforation 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 during the procedure for cardio embolic developed on the left cervical-ica (internal carotid artery) on (b)(6) 2020, three passes were performed using subject retriever along with microcathter.Physician then noted that there was vessel perforation with a possible casual relationship occurred during procedure.Before the procedure patient (b)(6) was 0 and immediately after (b)(6) was 2a.Patient (b)(6) before procedure was 0 and immediately after mrs was grade 4.No further information provided.

• 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: 10797180
• Report Number: 3012931345-2020-00185
• Device Sequence Number: 19571758
• 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): 01/07/2021

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: 07/08/2021
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000029497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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 (STRYKER); AXS CATALYST 6 (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR