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

Catalog Number 28-B2-26-100U

Device Problems Failure to Align (2522); Positioning Problem (3009); Activation Problem (4042)

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

Event Date 11/13/2020

Event Type  malfunction  

Event Description

The treo 26 x100 mb was positioned with the radiopaque markers under the lowest renal artery.The mb was deployed in the normal fashion with the contra lateral limb deployed and the proximal clasp retracted and released.A straight marker catheter was used and in position for angiograms.The bare stent was not fully expanded and without wall apposition, the radiopaque markers were not in alignment.Dr rizzo was concerned about not having full expansion of the bare stent, so the straight marker catheter was pulled down away from the bare stent.After the catheter was pulled down the open stent appeared to open.Dr.Rizzo cannulated the contra gate with a wire and catheter but decided to finish deploying the ipsi limb with removal of the mb delivery system to ensure the bare stent was released from the delivery system before placing the contra limb.After mb removal he used a 32 coda balloon to dilate the proximal neck stent graft.The contra limb was then deployed 17 x 100 followed by the ipsi limb 20 x100.Post angiogram was performed with the aneurysm sealed and no type i endoleak was seen.The main concern was the proximal clasp release and position of markers.Patient outcome: "aneurysm sealed, no adverse event.".

Event Description

The treo 26 x100 mb was positioned with the radiopaque markers under the lowest renal artery.The mb was deployed in the normal fashion with the contra lateral limb deployed and the proximal clasp retracted and released.A straight marker catheter was used and in position for angiograms.The bare stent was not fully expanded and without wall apposition, the radiopaque markers were not in alignment.Dr (b)(6)was concerned about not having full expansion of the bare stent, so the straight marker catheter was pulled down away from the bare stent.After the catheter was pulled down the open stent appeared to open.Dr.(b)(6) cannulated the contra gate with a wire and catheter but decided to finish deploying the ipsi limb with removal of the mb delivery system to ensure the bare stent was released from the delivery system before placing the contra limb.After mb removal he used a 32 coda balloon to dilate the proximal neck stent graft.The contra limb was then deployed 17 x 100 followed by the ipsi limb 20 x100.Post angiogram was performed with the aneurysm sealed and no type i endoleak was seen.The main concern was the proximal clasp release and position of markers.Patient outcome: "aneurysm sealed, no adverse event.".

• 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: 10971813
• MDR Text Key: 221294947
• Report Number: 2247858-2020-00066
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: 28-B2-26-100U
• Device Lot Number: 2006230110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR