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

Model Number 20212

Device Problems Premature Activation (1484); Device Dislodged or Dislocated (2923)

Patient Problem Perforation of Vessels (2135)

Event Date 10/03/2023

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred, resulting in vessel trauma and requiring additional surgical intervention.The target lesion was located in the non-tortuous and mildly calcified common iliac artery.After local anesthesia was administered, an 8.0x40x135 cm express ld vascular was advanced to treat the lesion.However, the stent's proximal end prematurely opened up and the stent dislodged without the balloon being inflated.The dislodged stent caused intimal injury and an embolectomy was performed as the stent could not be snared.The dislodged stent was successfully removed and no further patient complications were reported.

• 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: 17999878
• MDR Text Key: 326446204
• Report Number: 2124215-2023-57454
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031382226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• 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 Outcome(s): Required Intervention