MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 26650

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2020

Event Type  Injury  

Event Description

It was reported that the stent migrated.A 24 x 70mm x 75cm wallstent-uni endoprosthesis was selected for a procedure in the inferior vena cava (ivc).The device was implanted within the lesion in the ivc.Post-dilation was performed with a balloon.The stent migrated and became compressed within the next few minutes.This migrated stent remained implanted within the patient.Another 22 x 70mm wallstent was used to cover the lesion and complete the procedure.There were no patient complications reported and the patient was doing well.

Event Description

It was reported that the stent migrated.A 24 x 70mm x 75cm wallstent-uni endoprosthesis was selected for a procedure in the inferior vena cava (ivc).The device was implanted within the lesion in the ivc.Post-dilation was performed with a balloon.The stent migrated and became compressed within the next few minutes.This migrated stent remained implanted within the patient.Another 22 x 70mm wallstent was used to cover the lesion and complete the procedure.There were no patient complications reported and the patient was doing well.It was further reported the 70-80% stenosed target lesion was located in the non-tortuous and mildly calcified ivc.Pre-dilation was performed.The stent migrated to the lower end of the ivc and no attempt was made to remove the stent.The second stent was used to cover the lesion and the distal end of the migrated stent.

Event Description

It was reported that the stent migrated.A 24 x 70mm x 75cm wallstent-uni endoprosthesis was selected for a procedure in the inferior vena cava (ivc).The device was implanted within the lesion in the ivc.Post-dilation was performed with a balloon.The stent migrated and became compressed within the next few minutes.This migrated stent remained implanted within the patient.Another 22 x 70mm wallstent was used to cover the lesion and complete the procedure.There were no patient complications reported and the patient was doing well.It was further reported the 70-80% stenosed target lesion was located in the non-tortuous and mildly calcified ivc.Pre-dilation was performed.The stent migrated to the lower end of the ivc and no attempt was made to remove the stent.The second stent was used to cover the lesion and the distal end of the migrated stent.It was further reported that the post dilation was performed after deployment.The stent became downsized to 15-20mm post migration.

• Brand Name: WALLSTENT-UNI ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10904692
• MDR Text Key: 218268454
• Report Number: 2134265-2020-16412
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 26650
• Device Catalogue Number: 26650
• Device Lot Number: 0024644889
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR