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)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that the stent moved on the balloon.The target lesion was located in the right subclavian artery.An 8.0x20x135 cm express ld vascular stent balloon expandable was advanced for treatment.During the procedure, it was noted that the stent was detached from the sheath after entering the patient.The procedure was completed with a different device.No complications were reported, and the patient was stable.

Event Description

It was reported that the stent moved on the balloon.The target lesion was located in the right subclavian artery.An 8.0x20x135 cm express ld vascular stent balloon expandable was advanced for treatment.During the procedure, it was noted that the stent was detached from the sheath after entering the patient.The procedure was completed with a different device.No complications were reported, and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the express-vascular ld was returned for analysis.A visual examination identified that the balloon was not folded and had been subjected to positive pressure.No issues were noted with the balloon material.A visual examination identified that the stent had been displaced proximally from the balloon to a position on the shaft of the device approximately 13mm proximal of the proximal balloon sleeve.The displaced stent was undamaged.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the markerbands or tip.

• 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: 19034273
• MDR Text Key: 339268692
• Report Number: 2124215-2024-20031
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• 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: 0031690671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 52 KG