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

Catalog Number 28-N4-26-164-26S

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

"relay pro nbs navigate the thoracic aorta in step 1 with mechanical advantage, clinician moved in step 2 and try to use mechanical advantage and grey knob (using the disengagement button), to retract the constraining sleeve and deploys the graft, but he noticed a bending of the tip without releasing of the inner sheath.He tried to come back in step 1 to retract the device as soon as possible into outer sheath but he had again the bending of the tip.He tried to move in the device also in step 4 without consequence, so ho retract the entire system into abdominal aorta and convert the patient: he removed half the device from above and half from below (femoral access).Main clinician report is that step 2 didn't work." patient outcome - "abdominal aorta was expose and the device removed half from the aorta and half into femoral access.".

Event Description

"relay pro nbs navigate the thoracic aorta in step 1 with mechanical advantage, clinician moved in step 2 and try to use mechanical advantage and grey knob (using the disengagement button), to retract the constraining sleeve and deploys the graft, but he noticed a bending of the tip without releasing of the inner sheath.He tried to come back in step 1 to retract the device as soon as possible into outer sheath but he had again the bending of the tip.He tried to move in the device also in step 4 without consequence, so ho retract the entire system into abdominal aorta and convert the patient: he removed half the device from above and half from below (femoral access).Main clinician report is that step 2 didn't work.".Patient outcome - "abdominal aorta was expose and the device removed half from the aorta and half into femoral access.".

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 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: 17025351
• MDR Text Key: 317475993
• Report Number: 2247858-2023-00132
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Catalogue Number: 28-N4-26-164-26S
• Device Lot Number: B210602369
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2021
• 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