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

Catalog Number 28-B2-33-120U

Patient Problems Ambulation Difficulties (2544); Unspecified Vascular Problem (4441); Unspecified Musculoskeletal problem (4535)

Event Date 02/04/2021

Event Type  Injury  

Event Description

After an automobile accident, a 6.5 cm abdominal aortic aneurysm was found, and a bolton medical trio stent graft system was put in me (b)(6) 2021.My right leg began to have problems and a fen fen bypass surgery was done on me in (b)(6) of the same year but the doctor or the office never would tell me what was wrong and i switched to another vascular surgeon who did an angiogram and it says the right side of the stent is occluded.Now that something has changed with fda and bolton medical the first surgeon wants to call me in and do thoracic bypass surgery.I don't trust them because of the way they've kept things a secret and don't want him doing surgery on me ever again.I've reached out for help a few ways and haven't got any.I'm now living on disability and working delivering groceries for walmart when i can, i can't walk very far because my right leg starts to hurt and i have to wait a minute and then i can go again.The first surgeon put me down as having peripheral artery disease but i had no problems before he operated on me and was a new construction flooring subcontractor that ran up and downstairs and walked for miles as a search and rescue canine team volunteer, which is another reason i don't trust that surgeon.Any reply or help would be greatly appreciated.(b)(6) in (b)(6) did the original surgery.Reference reports: mw5147878, mw5147879.Refer to additional documents in i2k.

• Brand Name: TREO STENT GRAFT SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL INC.
• MDR Report Key: 18091995
• MDR Text Key: 327865951
• Report Number: MW5147877
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2023

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?: Yes
• Device Catalogue Number: 28-B2-33-120U
• Device Lot Number: 2012140171
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Patient Sequence Number: 1
• Treatment: 10 MG AMLODIPINE.; 20 MG FAMOTIDINE.; 20 MG LISINOPRIL.; VITAMIN D.; ZINC.
• Patient Outcome(s): Disability; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native