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

Catalog Number 28-N4-46-250-28U

Device Problem Material Invagination (1336)

Patient Problem Chest Pain (1776)

Event Date 04/10/2022

Event Type  malfunction  

Event Description

The physician called me on (b)(6) 2022.He stated that it appeared on a ct scan, done for the patient experiencing chest pain, the terumo graft looked "in-folded".He was taking the patient to have the graft ballooned, if that was unsuccessful, he would put a proximal gore graft.An intra-operative ivus shows the "in-fold" on the terumo graft and a post picture/run after gore graft.Patient outcome: "patient experienced "chest pain", physician stated to me that it "could be related, but he can't be sure".".

Event Description

The physician called me on 4/10/2022.He stated that it appeared on a ct scan, done for the patient experiencing chest pain, the terumo graft looked "in-folded".He was taking the patient to have the graft ballooned, if that was unsuccessful, he would put a proximal gore graft.An intra-operative ivus shows the "in-fold" on the terumo graft and a post picture/run after gore graft.Patient outcome - "patient experienced "chest pain", physician stated to me that it "could be related, but he can't be sure".

• Brand Name: RELAY PRO THORACIC STENT-GRAFT 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: 14160622
• MDR Text Key: 289885250
• Report Number: 2247858-2022-00068
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2024
• Device Catalogue Number: 28-N4-46-250-28U
• Device Lot Number: 2202250335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/10/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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): Other
• Patient Age: 99 YR
• Patient Sex: Female