MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-N4-34-154-34U

Device Problems Retraction Problem (1536); Separation Failure (2547)

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

Event Date 10/04/2021

Event Type  malfunction  

Event Description

The device was flushed on the back table and all components including the apex holder knob were in the appropriate positions.The device was brought to the surgical table and inserted into the patient's aorta via the right femoral artery.The device was advanced to the desired position in step 1 and unsheathed in step 2 as intended.Dr.Arnaoutakis then twisted the apex holder release (#3) to unlock and pulled it back, but the proximal clasp did not retract or release.He tried to retract it (#3) several more times, but it wouldn't go all the way back and the proximal clasp still did not release.Then dr.Back tried some more times, and then it did retract all the way and the proximal end was released.The remainder of the steps and procedure proceeded as normal.The incisions were closed, and the operation ended with successful lesion exclusion.The patient was extubated in the room, awake, and following commands moving all extremities.Patient outcome - "the device was ultimately completely deployed as intended with successful treatment, and there was no negative outcome/patient injury due to this event.".

• Brand Name: RELAY PRO THORACIC STENT-GRAFT SYSTEM
• Type of Device: STENT, ENDOVASCULAR 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: 12759036
• MDR Text Key: 282294619
• Report Number: 2247858-2021-00106
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200045
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 28-N4-34-154-34U
• Device Lot Number: 2106150368
• Date Manufacturer Received: 10/04/2021
• Date Device Manufactured: 07/31/2021
• 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: 75 YR
• Patient Sex: Male