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

Catalog Number	90182
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the thrombectomy procedure, the physician tried to move the high calcification clot out of the patient¿s anatomy with the subject stent retriever.Due to a narrowing in the patient¿s anatomy, the physician could not move the retriever through the internal carotid artery(ica).The physician then cut the pusher wire and left the subject retriever inside the vessel of the patient¿s anatomy.The procedure was completed successfully.No further information is available at the moment.
Event or Problem Description
It was reported that during the thrombectomy procedure, the physician tried to move the high calcification clot out of the patient¿s anatomy with the subject stent retriever.Due to a narrowing in the patient¿s anatomy, the physician could not move the retriever through the internal carotid artery(ica).The physician then cut the pusher wire and left the subject retriever inside the vessel of the patient¿s anatomy.The procedure was completed successfully.No further information is available at the moment.
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 subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 during the thrombectomy procedure, the physician tried to move the high calcification clot out of the patient¿s anatomy with the subject stent retriever.Due to a narrowing in the patient¿s anatomy, the physician could not move the retriever through the internal carotid artery (ica).The physician then cut the pusher wire and left the subject retriever inside the patient.Additional gfe information indicated that continuous flush was maintained, resistance was felt between the retriever and vessel during withdrawal, and a microcatheter was used with the subject device.This complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, procedural factors will be assigned to the reported event.

• 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: 10044707
• Report Number: 3012931345-2020-00072
• Device Sequence Number: 3014435
• Product Code: NRY
• UDI-Device Identifier: 00815742000528
• UDI-Public: 00815742000528
• 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): 07/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2021
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: TREVO PRO 18 MICRO CATHETER(STRYKER); TREVO PRO 18 MICRO CATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention