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

Catalog Number 28-M338145382490U

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Chest Pain (1776); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 02/02/2018

Event Type  Injury  

Event Description

"dissociation: on (b)(6) 2017: for zone 2 tever, the relay plus graft was deployed.(b)(6) 2018: the patient complained of chest pain.Catheter inspection was performed, but no anomalies were found.On (b)(6) 2018: in follow-up ct scanning, dissociation was found on the wall of brachiocephalic artery neighborhood lesser curvature side anterior of the ascending aorta.On (b)(6) 2018: the bare part of the graft was cut out and ascending arch replacement surgery was performed.The bare part stuck into the intima of the artery and the part torn.On (b)(6) 2018: the patient is still in hospital.The patient is currently recovering but still observed.".

• 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: 7740984
• MDR Text Key: 115765313
• Report Number: 2247858-2018-00149
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2018

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: 07/10/2018
• Device Catalogue Number: 28-M338145382490U
• Device Lot Number: 150713132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR