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 Vascular Dissection (3160)

Event Date 08/04/2022

Event Type  Injury  

Event Description

It was reported that stent dislodgement and vessel dissection occurred.The moderate to severe stenosed target lesion was located in left common carotid artery.A 8.0x40x135 cm express ld vascular stent was advanced but failed to reach the lesion due to tortuosity.However, it was noted that the stent was dislodged when advancing the guiding and fell into the right common iliac artery and the outlet of the dissection.The procedure was completed with a different device.No further patient complications reported and the patient 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15320874
• MDR Text Key: 298890389
• Report Number: 2124215-2022-31271
• 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
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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: 0028292864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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 Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG