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 Problems Dizziness (2194); Diaphoresis (2452); Foreign Body In Patient (2687); Unspecified Heart Problem (4454)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6).(e1) initial reporter phone: (b)(6).

Event Description

It was reported that stent dislodgement occurred requiring additional intervention.The patient presented with subclavian artery stenosis and underwent angiography and stent placement.The 85% stenosed target lesion was located in the non-angulated, mildly calcified, and moderately tortuous left subclavian artery.A guidewire and a boston scientific (bsc) catheter with 5f multifunctional catheter were sent to the opening of the proximal section of the left subclavian artery followed by tracking a bsc balloon catheter over wire.The lesion was dilated under working pressure and angiography showed that the stenosis in the left subclavian artery was improved and the distal blood flow increased.The left radial artery was punctured, and the radial artery catheter was successfully placed for angiographic positioning.The balloon was withdrawn, and a 9.0x40x135cm express ld stent was advanced over wire.However, the stent failed to reach the lesion despite many attempts and was dislodged in the right femoral artery upon withdrawal.During the procedure, the patient experienced palpitation, dizziness, and sweating.The lowest blood pressure noted was 82/52mmhg, and the heart rate fluctuated at 56-86 beats/min.Considering the vagus nerve reflex caused by the compression of the femoral artery, oral 5% glucose injection and dopamine pumping were done.Subsequently, the symptoms and vital signs gradually stabilized.Repeated attempts to use a 10f vascular sheath failed to retrieve the stent, and it was decided to perform right femoral artery repair procedure based on the patient condition.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16936088
• MDR Text Key: 315265700
• Report Number: 2124215-2023-20269
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 0028438283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG