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

Model Number 20226

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 05/06/2022

Event Type  Injury  

Event Description

It was reported that stent dislodgement inside the patient and removal difficulties were encountered.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac.A 9.0x40x75cm express ld stent was advanced for treatment.However, during the procedure, the stent delivery system failed to cross the lesion and then became difficult to remove from the lesion.When attempted to remove the device, the stent dislodged from the balloon.An attempt was made to deploy the dislodged stent with the balloon but it was unsuccessful.The balloon delivery system was removed.A non-bsc stent was used to affix and appose the dislodged express stent to the vessel wall.The procedure was completed with no patient complications reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14492825
• MDR Text Key: 292568020
• Report Number: 2134265-2022-05460
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392330
• UDI-Public: 08714729392330
• 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
• Report Date: 05/24/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027153933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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 Sex: Female
• Patient Race: White