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

Catalog Number 28-NC36N07030S2490

Device Problems Failure to Advance (2524); Component or Accessory Incompatibility (2897)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

We have a question regarding the eligibility of patient 014-026-zzz.He did not receive a terumo device due to complications during the procedure.The patient was supposed to receive a custom relay device on (b)(6) 2022.The device was unable to pass through an existing evar device.The left axillary artery was explored for bodyfloss, during which the patient became hypotensive due to bleeding in the external iliac artery.The bleeding was stopped using two excl uders and one viabahn stent.The relay device was not placed.After the surgery, another attempt was deemed not possible.The patient will therefore not be receiving a terumo device.There was uncertainty whether or not the patient should remain in the tiger study.On the one hand, no terumo device was or will be placed.On the other, the patient did meet all inclusion criteria and an attempt was made to place a terumo device, albeit unsuccessful.Not including the patient may paint a distorted picture of the risks of intervention, whether this was caused by the device or not.If the patient ought to remain in the study, we shall provide all relevant information regarding the intervention and follow-ups, and further follow-ups will continue to be planned for the tiger study.If the patient is deemed to be a screening failure, we shall act accordingly.Patient outcome - unknown.

Manufacturer Narrative

Bolton medical is voluntarily reporting an event related to a relay plus custom-made device.The custom made relay plus device is not marketed in the us.However; it is similar to the relay plus thoracic stent graft system approved for sale in the us (p110038).The event occurred in the netherlands.

Event Description

We have a question regarding the eligibility of patient (b)(6).He did not receive a terumo device due to complications during the procedure.The patient was supposed to receive a custom relay device on 27-1-2022.The device was unable to pass through an existing evar device.The left axillary artery was explored for bodyfloss, during which the patient became hypotensive due to bleeding in the external iliac artery.The bleeding was stopped using two excl uders and one viabahn stent.The relay device was not placed.After the surgery, another attempt was deemed not possible.The patient will therefore not be receiving a terumo device.There was uncertainty whether or not the patient should remain in the tiger study.On the one hand, no terumo device was or will be placed.On the other, the patient did meet all inclusion criteria and an attempt was made to place a terumo device, albeit unsuccessful.Not including the patient may paint a distorted picture of the risks of intervention, whether this was caused by the device or not.If the patient ought to remain in the study, we shall provide all relevant information regarding the intervention and follow-ups, and further follow-ups will continue to be planned for the tiger study.If the patient is deemed to be a screening failure, we shall act accordingly.Patient outcome - "unknown.".

Manufacturer Narrative

Bolton medical is voluntarily reporting an event related to a relay plus custom-made device.The custom made relay 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 (p110038).The event occurred in the netherlands.

• 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
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 14593805
• MDR Text Key: 301035661
• Report Number: 2247858-2022-00082
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110038
• 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: 07/07/2022

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: 01/06/2022
• Device Catalogue Number: 28-NC36N07030S2490
• Device Lot Number: 2112290084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2023
• 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: 99 YR