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

Catalog Number	90186
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012931345-2023-00177
• Device Sequence Number: 12604195
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/08/2023

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 Catalogue Number: 90186
• Device Lot Number: 0000036029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST TYPE 6F (STRYKER).; SOLITAIRE 6*24 (MEDTRONIC).; SOLITAIRE 6*40 (MEDTRONIC).; TREVO 3*20 (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown