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 05/10/2022

Event Type  Injury  

Event Description

It was reported that stent difficulty removal and stent dislodgement occurred resulting to a surgical intervention.The target lesion was located in iliac artery.A 7.0x60x135 cm express ld biliary stent was advanced but failed to cross the lesion.However, when tried to remove the device, the sheath was pulled out accidentally and the procedure was aborted.A week later, the patient was brought back to deploy the stent again but under fluoroscopy, it was noticed that the undeployed stent had come off the balloon and was still in the patient at the groin.The patient was then sent to another hospital for surgical removal.No further patient complications were reported.

Event Description

It was reported that stent difficulty removal and stent dislodgement occurred resulting to a surgical intervention.The target lesion was located in iliac artery.A 7.0x60x135 cm express ld biliary stent was advanced but failed to cross the lesion.However, when tried to remove the device, the sheath was pulled out accidentally and the procedure was aborted.A week later, the patient was brought back to deploy the stent again but under fluoroscopy, it was noticed that the undeployed stent had come off the balloon and was still in the patient at the groin.The patient was then sent to another hospital for surgical removal.No further patient complications were reported.It was further reported that the target lesion was 90% stenosed and patient required surgery to remove the stent and repair the artery.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14570024
• MDR Text Key: 293140840
• Report Number: 2134265-2022-05601
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• 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: 07/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024326455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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