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

Catalog Number 28-N230164302290S

Device Problem Disconnection (1171)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relaynbs plus thoracic stent-graft system.The relaynbs plus device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).The relaynbs plus related event occurred in (b)(6).

Event Description

During the performance of the relay nbs covered thoracic endoprosthesis placement procedure, the proximal safety of the endoprosthesis was disconnected, without having performed any delivery maneuver, remaining at the level of the abdominal aorta, compromising the visceral vessels.Thereafter, patient was admitted to the operating room as an emergency for bypass surgery of visceral vessels.Patient outcome - "-hemodialysis.-stanford b dissection endovascular treatment culminated.".

Event Description

During the performance of the relay nbs covered thoracic endoprosthesis placement procedure, the proximal safety of the endoprosthesis was disconnected, without having performed any delivery maneuver, remaining at the level of the abdominal aorta, compromising the visceral vessels.Thereafter, patient was admitted to the operating room as an emergency for bypass surgery of visceral vessels.Patient outcome - "-hemodialysis.-stanford b dissection endovascular treatment culminated.".

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relaynbs plus thoracic stent-graft system.The relaynbs plus device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).The relaynbs plus related event occurred in peru.

• 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
• MDR Report Key: 11084020
• MDR Text Key: 226647294
• Report Number: 2247858-2020-00079
• 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
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Catalogue Number: 28-N230164302290S
• Device Lot Number: B200924529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR