MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number	28-L2-24-080U
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Endoleak (4074)
Health Effect - Clinical Codes	Vascular Dissection (3160); Clinical Endoleak (4843)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"subject: (b)(6) had their 2-year follow-up on (b)(6) 2024 with a ct dated on (b)(6) 2024 which showed a tiny extravasation at posterior aspect of left iliac limb for possible endoleak (confirmed as type ia endoleak by the investigator), right common iliac artery (cia) dissection and 100mm x 94mm aneurysm.On (b)(6) 2024, the investigator met with the subject again to further discuss treatment options.He stated a fevar with pmeg would be most appropriate as the long terumo main body would allow pmeg placement more readily than a standard evar.An additional ct dated on (b)(6) 2024 noted the aneurysm was 'essentially unchanged measuring 98mm', the previously described endoleak was less conspicuous, and the right cia dissection was also unchanged.On (b)(6) 2024, the subject underwent a fevar using a pmeg device and coil embolization on the right internal iliac artery.The pmeg was implanted in the sma and bilateral renal arteries on a bifurcated modular platform with 4 fenestrations and 3 bridging stents.The coil embolization was performed using a 10mm pod device.The subject was admitted same-day for observation." patient outcome: "the event was considered as resolved at time of discharge on (b)(6) 2024 and is scheduled for a post-op ct on (b)(6) 2024 with additional follow-up after that.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2024-00262, device 2 is being reported under mdr-2247858-2024-00263, and device 3 is being reported under mdr.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.
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2024-00262, device 2 is being reported under mdr-2247858-2024-00263, and device 3 is being reported under mdr-2247858-2024-00264.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 or Problem Description
"subject (b)(6) had their 2-year follow-up on (b)(6)2024 with a ct dated (b)(6)2024 which showed a tiny extravasation at posterior aspect of left iliac limb for possible endoleak (confirmed as type ia endoleak by the investigator), right common iliac artery (cia) dissection and 100mm x 94mm aneurysm.On (b)(6)2024, the investigator met with the subject again to further discuss treatment options.He stated a fevar with pmeg would be most appropriate as the long terumo main body would allow pmeg placement more readily than a standard evar.An additional ct dated (b)(6)2024 noted the aneurysm was 'essentially unchanged measuring 98mm', the previously described endoleak was less conspicuous, and the right cia dissection was also unchanged.On (b)(6)2024, the subject underwent a fevar using a pmeg device and coil embolization on the right internal iliac artery.The pmeg was implanted in the sma and bilateral renal arteries on a bifurcated modular platform with 4 fenestrations and 3 bridging stents.The coil embolization was performed using a 10mm pod device.The subject was admitted same-day for observation." patient outcome - "the event was considered as resolved at time of discharge on (b)(6)2024 and is scheduled for a post-op ct on (b)(6)2024 with additional follow-up after that.".

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Common Device Name: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: matthew cleary ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 20474953
• Report Number: 2247858-2024-00264
• Device Sequence Number: 17949092
• Product Code: MIH
• UDI-Device Identifier: 08435761052036
• UDI-Public: 08435761052036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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 Expiration Date: 06/22/2024
• Device Catalogue Number: 28-L2-24-080U
• Device Lot Number: 2106180314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male