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

Catalog Number 28-B2-28-080X

Device Problem Material Separation (1562)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Core lab identified a 2nd new fracture next to the first one for subject 415-104.Upon internal review, the fracture involves the same apex as before.However, the aneurysm is completely re-absorbed, and the stent graft has not lost its original position.Patient outcome: "pending patient outcome.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under device 2 is being reported under mdr-2247858-2023-00059, and device 3 is being reported under mdr-2247858-2023-00060.

Event Description

Core lab identified a 2nd new fracture next to the first one for subject 415-104.Upon internal review, the fracture involves the same apex as before.However, the aneurysm is completely re-absorbed, and the stent graft has not lost its original position.Patient outcome: "pending patient outcome.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2023-00058, device 2 is being reported under mdr-2247858-2023-00059, and device 3 is being reported under mdr-2247858-2023-00060.

• Brand Name: TREO ABDOMINAL 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 ; 9548388699
• MDR Report Key: 16448862
• MDR Text Key: 310352414
• Report Number: 2247858-2023-00058
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: 10/28/2017
• Device Catalogue Number: 28-B2-28-080X
• Device Lot Number: 151116086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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 Age: 79 YR
• Patient Sex: Male