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

Catalog Number 28-B2-24-120S

Device Problems Break (1069); Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problems Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Heavily tortuous iliac access with calcifications.During introduction on the right side there was a lot of resistance and the mb didn't follow the stiff lunderquist wire; it got stuck at the right common iliac artery.Calcification ++ / tortuosity ++ the physician decided to exchange to an (b)(6) sheath first and tried to remove the main body device but then the nose cone broke and was left behind in the patient.The physicians decided to leave the nosecone in the abdominal aneurysm sac of the patient.Delivery system removed and with another mb completed the evar with access from the left side.All imaging is available and will be send over by the hospital for further investigation.Delivery system is in our possession (without the nose cone).Patient outcome - "there were no major adverse events, the nosecone is still in situ and is trapped behind the graft within the aneurysm sac.".

Event Description

Heavily tortuous iliac access with calcifications.During introduction on the right side there was a lot of resistance and the mb didn't follow the stiff lunderquist wire; it got stuck at the right common iliac artery.Calcification ++ / tortuosity ++ the physician decided to exchange to an 18f sheath first and tried to remove the main body device but then the nose cone broke and was left behind in the patient.The physicians decided to leave the nosecone in the abdominal aneurysm sac of the patient.Delivery system removed and with another mb completed the evar with access from the left side.All imaging is available and will be send over by the hospital for further investigation.Delivery system is in our possession (without the nose cone).Patient outcome - "there were no major adverse events, the nosecone is still in situ and is trapped behind the graft within the aneurysm sac.".

• 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
• MDR Report Key: 11634908
• MDR Text Key: 253733300
• Report Number: 2247858-2021-00039
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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: 03/11/2022
• Device Catalogue Number: 28-B2-24-120S
• Device Lot Number: B200304175
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR