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

Catalog Number 28-M340195402590S

Device Problems Patient Device Interaction Problem (4001); Failure to Seal (4070)

Patient Problem Paraplegia (2448)

Event Date 09/12/2023

Event Type  Injury  

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.

Event Description

"endoleak a1b an update received on 03/14/2024 from (b)(6) stating: as a reminder, the patient underwent treatment in (b)(6) 2022 for endovascular exclusion of a descending thoracic aneurysm through the placement of a thoracic endoprosthesis.Unfortunately, this procedure was complicated by spinal cord ischemia resulting in paraplegia.Additionally, the patient has been monitored for a thoracoabdominal aneurysm up until now.In january 2023, a discussion was held regarding the management of a celiac aortic aneurysm measuring 45mm in diameter.Following discussions in the vascular surgery multidisciplinary team meeting (rcp), it was decided to monitor the aneurysm for the time being due to the significant risk of complete paraplegia in case of extending coverage with a fenestrated endoprosthesis.Furthermore, the patient now presents with chronic renal failure, indicated by a gfr of 26ml/min, with a significant risk of renal function decline.Following analysis of the non-contrast ct scan and doppler ultrasound performed on 09/12/2023, the doppler study revealed progression of the celiac aortic aneurysm, which now measures 52mm in diameter compared to 45mm six months ago.The non-contrast ct scan conducted indicated a progression of the celiac aorta by 2 to 3 mm over 6 months.However, the most concerning finding is the progression of the descending thoracic aorta by more than 5mm on some cuts, now exceeding 60mm in diameter.This increase is attributed to the evolution of the thoracoabdominal junction and a loss of distal seal of the thoracic endoprosthesis.Although the scanner was not contrast-enhanced and the doppler did not assess the thoracic aorta, we can infer that it represents a type a1b endoleak.The surgeon suggested to the patient the continuation of treatment through extension with a fenestrated endoprosthesis for the 4 visceral arteries to address the thoracoabdominal junction aneurysm and, more importantly, to exclude the progressing thoracic aneurysm.Unfortunately, the patient has declined any intervention for the time being, but is scheduled for a follow-up visit in july.Hi pedro please advise if you need additional information site have not uploaded scans." patient outcome: "ongoing".

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.

Event Description

"endoleak a1b an update received on 03/14/2024 from dhaliwal saminderjit stating: as a reminder, the patient underwent treatment in (b)(6) 2022 for endovascular exclusion of a descending thoracic aneurysm through the placement of a thoracic endoprosthesis.Unfortunately, this procedure was complicated by spinal cord ischemia resulting in paraplegia.Additionally, the patient has been monitored for a thoracoabdominal aneurysm up until now.In (b)(6) 2023, a discussion was held regarding the management of a celiac aortic aneurysm measuring 45mm in diameter.Following discussions in the vascular surgery multidisciplinary team meeting (rcp), it was decided to monitor the aneurysm for the time being due to the significant risk of complete paraplegia in case of extending coverage with a fenestrated endoprosthesis.Furthermore, the patient now presents with chronic renal failure, indicated by a gfr of 26ml/min, with a significant risk of renal function decline.Following analysis of the non-contrast ct scan and doppler ultrasound performed on (b)(6) 2023, the doppler study revealed progression of the celiac aortic aneurysm, which now measures 52mm in diameter compared to 45mm six months ago.The non-contrast ct scan conducted indicated a progression of the celiac aorta by 2 to 3 mm over 6 months.However, the most concerning finding is the progression of the descending thoracic aorta by more than 5mm on some cuts, now exceeding 60mm in diameter.This increase is attributed to the evolution of the thoracoabdominal junction and a loss of distal seal of the thoracic endoprosthesis.Although the scanner was not contrast-enhanced and the doppler did not assess the thoracic aorta, we can infer that it represents a type a1b endoleak.The surgeon suggested to the patient the continuation of treatment through extension with a fenestrated endoprosthesis for the 4 visceral arteries to address the thoracoabdominal junction aneurysm and, more importantly, to exclude the progressing thoracic aneurysm.Unfortunately, the patient has declined any intervention for the time being, but is scheduled for a follow-up visit in (b)(6).Hi pedro please advise if you need additional information site have not uploaded scans." patient outcome: "ongoing".

Event Description

"endoleak a1b.An update received on 03/14/2024 from (b)(6) stating: as a reminder, the patient underwent treatment in (b)(6) 2022 for endovascular exclusion of a descending thoracic aneurysm through the placement of a thoracic endoprosthesis.Unfortunately, this procedure was complicated by spinal cord ischemia resulting in paraplegia.Additionally, the patient has been monitored for a thoracoabdominal aneurysm up until now.In (b)(6) 2023, a discussion was held regarding the management of a celiac aortic aneurysm measuring 45mm in diameter.Following discussions in the vascular surgery multidisciplinary team meeting (rcp), it was decided to monitor the aneurysm for the time being due to the significant risk of complete paraplegia in case of extending coverage with a fenestrated endoprosthesis.Furthermore, the patient now presents with chronic renal failure, indicated by a gfr of 26ml/min, with a significant risk of renal function decline.Following analysis of the non-contrast ct scan and doppler ultrasound performed on (b)(6) 2023, the doppler study revealed progression of the celiac aortic aneurysm, which now measures 52mm in diameter compared to 45mm six months ago.The non-contrast ct scan conducted indicated a progression of the celiac aorta by 2 to 3 mm over 6 months.However, the most concerning finding is the progression of the descending thoracic aorta by more than 5mm on some cuts, now exceeding 60mm in diameter.This increase is attributed to the evolution of the thoracoabdominal junction and a loss of distal seal of the thoracic endoprosthesis.Although the scanner was not contrast-enhanced and the doppler did not assess the thoracic aorta, we can infer that it represents a type a1b endoleak.The surgeon suggested to the patient the continuation of treatment through extension with a fenestrated endoprosthesis for the 4 visceral arteries to address the thoracoabdominal junction aneurysm and, more importantly, to exclude the progressing thoracic aneurysm.Unfortunately, the patient has declined any intervention for the time being, but is scheduled for a follow-up visit in july.Hi pedro please advise if you need additional information site have not uploaded scans." patient outcome: "ongoing".

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.This subseqent follow-up reprort for complaint # (b)(4) is being submitted due to the incorrect follow-up evaluation report being attached in the "file attachments" section of this form3500a.An updated, corrected report has been attached.- mr 05/21/2024.

• Brand Name: RELAY PLUS 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: 18925564
• MDR Text Key: 337945635
• Report Number: 2247858-2024-00061
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/21/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-M340195402590S
• Device Lot Number: B200715182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 02/23/2024
• Supplement Dates FDA Received: 04/24/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2020
• 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: 75 YR
• Patient Sex: Female