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

Catalog Number 28-B2-30-100U

Device Problem Failure to Advance (2524)

Patient Problems Aneurysm (1708); Calcium Deposits/Calcification (1758); Rupture (2208)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Type 1a endo leak observed at level of calcified shelf in proximal neck.Type 1b endo leak observed after ballooning with coda balloon.Difficulty passing 14fr 46mm coda post ballooning.Difficulty seeing primary sheath during cuff placement.Lack of proper visibility with sheath tip - per physician.Difficulty passing main body as well as limb extensions due to calcified arteries.Ruptured iliac at level of hypogastric.Patient outcome - "type 1a and 1b endoleak resolved with cuff placement as well as palmaz stent placement and ruptured iliac was resolved with coiled hypogastric artery and placement of 15x100 treo limb extension".

Event Description

Type 1a endo leak observed at level of calcified shelf in proximal neck, type 1b endo leak observed after ballooning with coda balloon, difficulty passing 14fr 46mm coda post ballooning, difficulty seeing primary sheath during cuff placement, lack of proper visibility with sheath tip - per physician, difficulty passing main body as well as limb extensions due to calcified arteries, ruptured iliac at level of hypogastric.Patient outcome - "type 1a and 1b endoleak resolved with cuff placement as well as palmaz stent placement and ruptured iliac was resolved with coiled hypogastric artery and placement of 15x100 treo limb extension".

• 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: 11842569
• MDR Text Key: 251360799
• Report Number: 2247858-2021-00048
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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 Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: 28-B2-30-100U
• Device Lot Number: 2007170352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR