MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during the procedure, the physician used infinity, ace 68 and velocity catheter.Physician deployed the subject stent retriever and upon retrieval, the stent of the subject stent retriever broke from the delivery wire.The physician used a second stent retriever as a snare device to successfully retrieve the broken stent from the patient's middle cerebral artery.The physician replaced it with a new retriever and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration 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 event was not confirmed and it cannot be confirmed if 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.As per additional information there was a second trevo used to snare initial trevo, and the patient's anatomy was very tortuous.It is probable that the device was damaged during navigation through the tortuous anatomy.An assignable cause of procedural factors will be assigned to the reported event, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the physician used infinity, ace 68 and velocity catheter.Physician deployed the subject stent retriever and upon retrieval, the stent of the subject stent retriever broke from the delivery wire.The physician used a second stent retriever as a snare device to successfully retrieve the broken stent from the patient's middle cerebral artery.The physician replaced it with a new retriever and continued the procedure without clinical consequences to the patient.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 10054655
• Report Number: 3012931345-2020-00073
• Device Sequence Number: 2783636
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143077
• 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): 07/09/2020

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 Expiration Date: 08/27/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000032047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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: ACE 68 CATHETER (PENUMBRA); INFINITY CATHETER (STRYKER); TREVO RETRIEVER (STRYKER); ACE 68 CATHETER (PENUMBRA); INFINITY CATHETER (STRYKER); TREVO RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention