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

Catalog Number 90186

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  Injury  

Event Description

It was reported that during the thrombectomy procedure on (b)(6) 2020, the patient suffered from hemorrhagic transformation-blood brain barrier rupture.It was reported there was a possible relationship between the adverse event and subject retriever device used in the procedure.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.The event resolved with unknown clinical sequalae on (b)(6) 2020.No further information is available.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Manufacturer Narrative

It was confirmed on 21 aug 2023 that the same reported event details, facility, device, and event date captured in this event was already captured under mfr report number: 3012931345-2023-00170.Therefore this complaint no longer meets reporting criteria and and a supplemental will be filed as a duplicate/cancellation record.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during the thrombectomy procedure on (b)(6) 2020, the patient suffered from hemorrhagic transformation-blood brain barrier rupture.It was reported there was a possible relationship between the adverse event and subject retriever device used in the procedure.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.The event resolved with unknown clinical sequalae on (b)(6) 2020.No further information is available.It was confirmed on 21 aug 2023 that the same reported event details, facility, device, and event date captured in this event was already captured under mfr report number: 3012931345-2023-00170.Therefore this complaint no longer meets reporting criteria and and a supplemental will be filed as a duplicate/cancellation record.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17447286
• MDR Text Key: 320280566
• Report Number: 3012931345-2023-00177
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90186
• Device Lot Number: 0000036029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATALYST TYPE 6F (STRYKER).; SOLITAIRE 6*24 (MEDTRONIC).; SOLITAIRE 6*40 (MEDTRONIC).; TREVO 3*20 (STRYKER).
• Patient Outcome(s): Other