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

Catalog Number 28M334200342490U

Device Problems Leak/Splash (1354); Premature Activation (1484); Device Slipped (1584)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/09/2015

Event Type  Other  

Manufacturer Narrative

Bolton medical is awaiting additional info about the case in order to conduct an investigation.

Event Description

Case report reported as: "back end of graft.Deployed in primary sheath - dr.Moved black stationary grip to grey deployment.This action free up the graft from deployment sheath.- graft fell back from target vessel leaving a slight type i endo leak.- a 34x100 was used as an extension which resolved the endo leak.And.Result success/good outcome achieved.".

Manufacturer Narrative

This follow-up report includes the attached evaluation.This emdr was originally submitted through the test emdr system on 11/16/2015 instead of the production emdr system due to issues my firm encountered when enrolling in emdr.This report reflects the date in which the report was resubmitted to the production emdr system of the database following advice from fda's emdr help desk.However, as the original report was submitted on 11/16/2015 and acknowledged by fda on 11/17/2015.

• Brand Name: RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: jesica mclane ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 4995422
• MDR Text Key: 23392932
• Report Number: 2247858-2015-00015
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/08/2016

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: 08/28/2017
• Device Catalogue Number: 28M334200342490U
• Device Lot Number: 140903048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• 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