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

Catalog Number 28-N4-36-154-32U

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Perforation of Vessels (2135)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Thoraflex was used in previous case to treat a redo chronic type a dissection.This case's plan was to expand with relay pro to distal to celiac.Two tapers needed to be used.Physician wanted to deploy first taper distally and then the next taper inside of it (this is the only way to get more than 50mm overlap when using 2 tapers).The anatomy was very tortuous.Physician had arm prepped to do body floss technique but decided to not do it and just try to track the relay pro without the floss.The first relay was deployed 32x28x154.It landed proximally in the biggest curve.We had a hard time pulling back the nose comb.It was getting caught on the stent and the stent looked like it was dragging with the nose comb.We did multiple troubleshooting steps to get it out.Most of it including pushing nose comb up and then as it was being pulled back to try to rotate the cannula.All these steps made the distal stent of the relay pro push up and it tore the septum of the dissection.After we got the nose comb finally back, the doctor switched plans to get body floss and then we deployed 2nd relay pro 40x36x204.The removal of the nose comb of 2nd relay was still hard with the body floss.It was catching on every angle of the aorta as it was coming down.Physician made a comment on (b)(6) 2023 during a different case that the relay pro has a design flaw of the nose comb that it doesn't take curved aortas well.He used gore for thoraflex extension case recently because he didn't have confidence in relay pro in tortuous chronic dissected aorta.Patient outcome: "patient had the septum rupture of true and false lumen during the removal of relay pro.There is a high risk of malperfusion of visceral arteries because of this and the physician placed a cook dissection peticoat across visceral to try to lower the risk.".

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: RELAY PRO NBS 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: 18105002
• MDR Text Key: 327875666
• Report Number: 2247858-2023-00285
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-36-154-32U
• Device Lot Number: 2303240119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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: 52 YR
• Patient Sex: Female