TREVO XP PROVUE 3MM X 20MM 90183

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-14 for TREVO XP PROVUE 3MM X 20MM 90183 manufactured by Stryker Neurovascular-utah-salt Lake City.

MAUDE Entry Details

• Report Number: 3012931345-2020-00040
• MDR Report Key: 9833037
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-14
• Date of Report: 2020-04-02
• Date of Event: 2019-12-28
• Date Mfgr Received: 2020-04-02
• Device Manufacturer Date: 2018-09-14
• Date Added to Maude: 2020-03-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. TARA LOPEZ
• Manufacturer Street: 47900 BAYSIDE PARKWAY
• Manufacturer City: FREMONT CA 94538
• Manufacturer Country: US
• Manufacturer Postal: 94538
• Manufacturer Phone: 5104132500
• Manufacturer G1: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
• Manufacturer Street: 4870 WEST 2100 SOUTH
• Manufacturer City: SALT LAKE CITY UT 84120
• Manufacturer Country: US
• Manufacturer Postal Code: 84120
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• Generic Name: CATHETER, THROMBUS RETRIEVER
• Product Code: NRY
• Date Received: 2020-03-14
• Model Number: 90183
• Catalog Number: 90183
• Lot Number: 0000014827
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
• Manufacturer Address: 4870 WEST 2100 SOUTH SALT LAKE CITY UT 84120 US 84120

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-14