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

Model Number 20226

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that the stent dislodged outside the patient.The patient was being treated for iliac stenosis and underwent stenting.The greater than 70% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0x30x75cm express ld iliac / biliary stent was advanced for treatment but failed to cross the lesion.During removal, the stent came off the wire outside the patient.Another 6.0x30x75cm express ld iliac / biliary stent was advanced but also failed to cross the lesion.The procedure was completed with a non-boston scientific stent.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of an express ld.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent was detached from the balloon and was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.

Event Description

It was reported that the stent dislodged outside the patient.The patient was being treated for iliac stenosis and underwent stenting.The greater than 70% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0x30x75cm express ld iliac / biliary stent was advanced for treatment but failed to cross the lesion.During removal, the stent came off the wire outside the patient.Another 6.0x30x75cm express ld iliac / biliary stent was advanced but also failed to cross the lesion.The procedure was completed with a non-boston scientific stent.No patient complications were reported.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18720647
• MDR Text Key: 335577151
• Report Number: 2124215-2024-08820
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579656
• UDI-Public: 08714729579656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030430130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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