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

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2022-05601
• Device Sequence Number: 6146909
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown