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

Catalog Number 28-M130155262285S

Device Problems Collapse (1099); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relay transport thoracic stent-graft system.The relay transport 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 relay transport related event occurred in (b)(6).

Event Description

"patients diagnosed with thoracic descending aorta multiple ulcers merger intramural hematoma, cta showed no obvious calcified plaque, diameter of 27mm, right femoral artery diameter 9.7 mm in diameter, 28 - m130155262285s intraoperative selection model, used cook hard guide wire to deliver relay transportation support system.When 10cm of the relay outer sheath into the common femoral artery, the whole system got stuck.Dsa scan showed taped guide head and the delivery system collapsed and separated.So, the delivery system couldn't push.The surgeon had to slowly pulled the stent system out of the body, and cost several hours to remove the detached taped head.Therefore, the doctor believed that the stent had quality problems and required it to be scrapped." patient outcome: "no injury to the patient.".

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relay transport thoracic stent-graft system.The relay transport 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 relay transport related event occurred in china.

Event Description

"patients diagnosed with thoracic descending aorta multiple ulcers merger intramural hematoma, cta showed no obvious calcified plaque, diameter of 27mm, right femoral artery diameter 9.7 mm in diameter, 28 - m130155262285s intraoperative selection model, used cook hard guide wire to deliver relay transportation support system.When 10cm of the relay outer sheath into the common femoral artery, the whole system got stuck.Dsa scan showed taped guide head and the delivery system collapsed and separated.So, the delivery system couldn't push.The surgeon had to slowly pulled the stent system out of the body, and cost several hours to remove the detached taped head.Therefore, the doctor believed that the stent had quality problems and required it to be scrapped." patient outcome: "no injury to the patient.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise, fl FL 33325
• MDR Report Key: 9560518
• MDR Text Key: 194483372
• Report Number: 2247858-2020-00001
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Catalogue Number: 28-M130155262285S
• Device Lot Number: B190711108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR