MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number 20226

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that stent premature deployment occurred.The stenosed target lesion was located in the severely calcified brachial artery and a shockwave device was performed.An 8.0x30x75cm express ld stent balloon expandable was crossed for treatment.However, when the device was pulled back to be repositioned for more precision, the stent slid off of the stent balloon catheter, thus dislodged inside the patient.The device was taken out by snaring through the femoral artery and was fully recovered.There were no fragments left inside the body and the procedure was completed via angioplasty with another device.There were no patient complications nor injuries reported.

Event Description

It was reported that stent premature deployment occurred.The stenosed target lesion was located in the severely calcified brachial artery and a shockwave device was performed.An 8.0x30x75cm express ld stent balloon expandable was crossed for treatment.However, when the device was pulled back to be repositioned for more precision, the stent slid off of the stent balloon catheter, thus dislodged inside the patient.The device was taken out by snaring through the femoral artery and was fully recovered.There were no fragments left inside the body and the procedure was completed via angioplasty with another device.There were no patient complications nor injuries reported.It was further reported that the correct complaint device was an 8 x 60 x 130 innova stent.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18302811
• MDR Text Key: 330183333
• Report Number: 2124215-2023-69999
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030921227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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