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

Catalog Number 28-B2-30-120S

Device Problem Difficult to Open or Close (2921)

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

Event Date 09/24/2020

Event Type  malfunction  

Event Description

"first the main body was deployed until the cl leg was open, with no problems.We performed an cta to check if the renal arteries were open, and position was a bit to low.(due to the fact a breath hold was not possible) the physician pushed the mb a bit upwards and checked the renals with another angio.Position was ok.Then the physician pushed the grey knob and turned it.He experienced a bit of friction to push and turn it.After he successfully turned the grey knob, we checked position again; this was ok.Then he pulled the black release grip towards the flushing port with no problems.Under fluoroscopy we saw the clasp retracting.But then the bare spring was still captured, even though the black release grip was completely retracted.As a solution we manually kept the main body in position, cannulated the cl leg, exchanged for a stiff wire and advanced an 12f sheath towards the bare stent.After a push of this 12f sheath the bare spring did not open completely.We decided to complete the ipsilateral side of the main body and we inflated the molding balloon in the first covered stent with the shoulders of the balloon pushing against the bare springs.Then we moved the complete delivery system a bit distally and luckily the bare springs opened completely.The main body was retracted a bit to distally and we had to place a cuff extension.Final angio presented a successful evar with ra open, hypogastric open and no endoleaks." patient outcome: "no adverse events.".

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Type of Device: STENT, ENDOVASCUALR 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: 10723121
• MDR Text Key: 214805430
• Report Number: 2247858-2020-00046
• 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
• Report Date: 10/22/2020

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: 06/21/2022
• Device Catalogue Number: 28-B2-30-120S
• Device Lot Number: B200612287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2020
• 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 Age: 77 YR