MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20212

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that stent dislodged from the balloon inside the patient.An express ld balloon expandable stent was selected for use to stent to coeliac axis.The patient had an aortic-bifemoral bypass graft, so the degree of angulation to the origin of the coeliac was greater than normal.A directional non-bsc tourguide sheath and a non-bsc guidewire were passed into the distal hepatic artery.An attempt was made to the pass the sheath into the coeliac, but the degree of angulation would not allow the sheath to pass.The express ld balloon expandable stent was attempted to be passed into the coeliac.However, the degree of angulation prevented the stent from advancing.The stent was withdrawn, but the back of the stent appeared to have opened slightly.The stent then dislodged from the balloon as it came to the end of the sheath.The non-bsc guidewire remained in place allowing the stent to be snared.An unsuccessful attempt was made to remove the stent through a larger sheath that was placed.The patient was transferred for surgical removal of the stent.There were no patient complications, and the patient was well post-procedure.

• Brand Name: EXPRESS LD VASCULAR
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17599986
• MDR Text Key: 321711632
• Report Number: 2124215-2023-44865
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0027846480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Treatment: INTRODUCER SHEATH: TOURGUIDE; ROSEN GUIDEWIRE
• Patient Outcome(s): Other