MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-M346250422690U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 03/24/2018

Event Type  Death  

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2018-00165.Device 2 is being reported under mdr 2247858-2018-00166.

Event Description

"post op day one, the pt suffered a minor stroke.Post op day two, the pt became hypotensive and tachycardic.They treated the patient and he seemed better; however on post op day three, he became even more hypotensive and bradycardic.Dr.(b)(6) took the patient straight into the o.R and tried to cross clamp his aorta but the patient became unresponsive.Cpr was performed but the patient died on the table.Time of death was 2109 on (b)(6) 2018." patient outcome: "the patient died.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 7899426
• MDR Text Key: 121431660
• Report Number: 2247858-2018-00166
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Catalogue Number: 28-M346250422690U
• Device Lot Number: 171228250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 66 YR