MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD E-LUMINEX BILIARY STENT; BARE METAL BILIARY STENT

Model Number ZBM1240

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/31/2017

Event Type  Death  

Event Description

During stent placement in the infra-renal abdominal artery, an aortic leak developed.Despite aggressive resuscitation, pt expired after being transferred to another facility for vascular intervention.

• Brand Name: BARD E-LUMINEX BILIARY STENT
• Type of Device: BARE METAL BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 7222009
• MDR Text Key: 98353276
• Report Number: 7222009
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 040495109010366
• UDI-Public: (01)040495109010366
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2017,08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Model Number: ZBM1240
• Device Catalogue Number: ZBM1240
• Device Lot Number: ANAV1634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Distributor Facility Aware Date: 08/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 56