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

Model Number 20212

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the subclavian artery.A 10.0x30x135 cm express ld vascular stent was selected for use; however, during unpacking, it was noted that the tip of the stent was lifted.The physician adjusted the stent and tried to cross the 7f sheath but the lifted part of the stent failed to cross.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the subclavian artery.A 10.0x30x135 cm express ld vascular stent was selected for use; however, during unpacking, it was noted that the tip of the stent was lifted.The physician adjusted the stent and tried to cross the 7f sheath but the lifted part of the stent failed to cross.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

(h6) device codes updated from failure to advance- a150204 to difficult to advance- a150205.

Manufacturer Narrative

A express ld batch # 27502743, 12 atm was returned for analysis.A visual examination of the returned device confirmed that the balloon was tightly folded and had not been subjected to positive pressure.No issues were noted with the balloon material.The first two rows of the proximal stent struts were found to be lifted/damaged.No issues were noted with the tip of the device.This concludes the product analysis.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the subclavian artery.A 10.0x30x135 cm express ld vascular stent was selected for use; however, during unpacking, it was noted that the tip of the stent was lifted.The physician adjusted the stent and tried to cross the 7f sheath but the lifted part of the stent failed to cross.The device was removed and the procedure was completed 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13253558
• MDR Text Key: 283787581
• Report Number: 2134265-2022-00229
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

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 Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0027502743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/17/2022; 03/15/2022
• Supplement Dates FDA Received: 01/25/2022; 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG