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

Catalog Number 28-B2-30-080U

Device Problems Fluid/Blood Leak (1250); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

The above listed treo bifurcate delivery system was removed from both layers of sterile packaging and placed on a sterile or side table.It was removed from the tray insert without issue and laid flat on the draped surface for prep.The scrub tech flushed the guidewire lumen port without issue but when attempting to flush the device through the side port, saline leaked through the base of the port where it is attached to the sheath body.The leak was significant enough that saline did not exit the sheath where it meets the device tip.Multiple attempts were made to adjust the union of the syringe and luer-lock but this did not remedy the issue.I instructed the scrub tech to push down on the body of the syringe as she pushed the plunger, in hopes that downward pressure would close the leaking area enough to force the hep saline through the sheath and adequately purge the treo graft.Using this downward pressure, the she was able to flush enough saline that it exited the sheath tip per protocol.I informed dr nagarsheth of the issue.Not having a substitute for this device readily available, dr nagarsheth decided to proceed with the case voicing that we would monitor any potential back bleeding/blood loss.Once inserted into the patient, blood began to leak through the side port almost immediately.Dr nagarsheth proceeded to deploy this treo device per ifu, but at the point of gate cannulation, enough blood had leaked through the side port to saturate 3 ray-tec sponges.I then asked dr nagarsheth if he would consider deviating from protocol by deploying the ipsi portion of the main body, removing the delivery system and replacing it with a standard sheath.He chose to employ this deviation of protocol after he cannulated the gate and advanced the guidewire and catheter into the dta to ensure continued wire access into the contra gate.At this point, instead of proceeding with measuring for/deploying contra limb, he instead deployed the ipsi portion of the main body and removed the entire system from the patient.He replaced the main body delivery system with a 16fr dry seal sheath and then continued the remainder of the procedure per ifu.Patient outcome: "the amount of blood lost did not require the introduction of any blood products to the patient during the procedure and the completion angiogram ultimately showed successful exclusion of the aneurysm.".

Event Description

The above listed treo bifurcate delivery system was removed from both layers of sterile packaging and placed on a sterile or side table.It was removed from the tray insert without issue and laid flat on the draped surface for prep.The scrub tech flushed the guidewire lumen port without issue but when attempting to flush the device through the side port, saline leaked through the base of the port where it is attached to the sheath body.The leak was significant enough that saline did not exit the sheath where it meets the device tip.Multiple attempts were made to adjust the union of the syringe and luer-lock but this did not remedy the issue.I instructed the scrub tech to push down on the body of the syringe as she pushed the plunger, in hopes that downward pressure would close the leaking area enough to force the hep saline through the sheath and adequately purge the treo graft.Using this downward pressure, the she was able to flush enough saline that it exited the sheath tip per protocol.I informed dr (b)(6) of the issue.Not having a substitute for this device readily available, dr (b)(6) decided to proceed with the case voicing that we would monitor any potential back bleeding/blood loss.Once inserted into the patient, blood began to leak through the side port almost immediately.Dr (b)(6) proceeded to deploy this treo device per ifu, but at the point of gate cannulation, enough blood had leaked through the side port to saturate 3 ray-tec sponges.I then asked dr (b)(6) if he would consider deviating from protocol by deploying the ipsi portion of the main body, removing the delivery system and replacing it with a standard sheath.He chose to employ this deviation of protocol after he cannulated the gate and advanced the guidewire and catheter into the dta to ensure continued wire access into the contra gate.At this point, instead of proceeding with measuring for/deploying contra limb, he instead deployed the ipsi portion of the main body and removed the entire system from the patient.He replaced the main body delivery system with a 16fr dry seal sheath and then continued the remainder of the procedure per ifu.Patient outcome: "the amount of blood lost did not require the introduction of any blood products to the patient during the procedure and the completion angiogram ultimately showed successful exclusion of the aneurysm.".

• 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: 11388588
• MDR Text Key: 238618535
• Report Number: 2247858-2021-00018
• 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: 04/20/2021

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: 09/04/2022
• Device Catalogue Number: 28-B2-30-080U
• Device Lot Number: 2008240317
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1