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

Model Number 20212

Device Problems Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 9.0x30x135 cm express ld vascular was selected for treatment on the iliac artery stenosis and used to cross an 8f artery sheath.However, the device would not cross after several attempts.The stent was then damaged.The device was replaced with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device eval by manufacturer: the express ld device batch number 28076768 was received for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.Further inspection identified that the distal end of the stent was damaged where the stent had been pushed proximally over the balloon cone and a stent strut at the distal end was raised.No issues were identified with the shaft or tip during the product analysis.The damage to the stent was confirmed through analysis, which likely occurred when the user was attempting to insert the device into the sheath during insertion.

Event Description

It was reported that stent damage occurred.A 9.0x30x135 cm express ld vascular was selected for treatment on the iliac artery stenosis and used to cross an 8f artery sheath.However, the device would not cross after several attempts.The stent was then damaged.The device was replaced with a different device.There were no patient complications reported and the patient status was stable.

• 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: 18388644
• MDR Text Key: 331395783
• Report Number: 2124215-2023-72691
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0028076768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG