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

Catalog Number 28-B2-26-080U

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584); Difficult or Delayed Separation (4044)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

Bifurcate graft was positioned at intended landing zone in an angled neck.The gray portion of the delivery system was pushed and rotated.The black slider was moved caudally.The gate was deployed, and the contra limb was deployed, as well as the ipsi lateral limb was deployed.Upon attempted removal of the delivery system, the surgeon encountered resistance.At this point we saw of the stents on the crown of the graft appeared to be constrained.It appeared caught in the proximal housing.When dr.(b)(6) released pressure and let the delivery system relax, he noticed the black slider was easily movable.He advanced the black slider easily and the tyne released.The surgeon gently spun the entire system as he was withdrawing the entire system through the groin.Upon final angiogram, the graft was approximately 6 mm below the lower renal.We had to place a cuff to resolve the leak.Patient outcome: "after leak resolved, graft was ballooned, and access was closed.".

Event Description

Bifurcate graft was positioned at intended landing zone in an angled neck.The gray portion of the delivery system was pushed and rotated.The black slider was moved caudally.The gate was deployed, and the contra limb was deployed, as well as the ipsi lateral limb was deployed.Upon attempted removal of the delivery system, the surgeon encountered resistance.At this point we saw of the stents on the crown of the graft appeared to be constrained.It appeared caught in the proximal housing.When dr.Yoon released pressure and let the delivery system relax, he noticed the black slider was easily movable.He advanced the black slider easily and the tyne released.The surgeon gently spun the entire system as he was withdrawing the entire system through the groin.Upon final angiogram., the graft was approximately 6 mm below the lower renal.We had to place a cuff to resolve the leak.Patient outcome - "after leak resolved, graft was ballooned, and access was closed.".

• 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 ; 9548389699
• MDR Report Key: 15695087
• MDR Text Key: 307159646
• Report Number: 2247858-2022-00166
• 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: 02/03/2023

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: 02/24/2024
• Device Catalogue Number: 28-B2-26-080U
• Device Lot Number: 2102100294
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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: 79 YR
• Patient Sex: Female