MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number 26280

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the iliac artery.A 14x90/9fr wallstent uni was advanced for treatment.During the use of iliac vein stent, the stent could not be deployed and pushed out.However, it was found that the tip end of the stent strut was lifted up and it was bent, resulting in the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported.

Event Description

It was reported that stent damage occurred.The target lesion was located in the iliac artery.A 14x90/9fr wallstent uni was advanced for treatment.During the use of iliac vein stent, the stent could not be deployed and pushed out.However, it was found that the tip end of the stent strut was lifted up and it was bent, resulting in the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported.It was further reported that the target lesion was severely stenosed.

Event Description

It was reported that stent damage occurred.The target lesion was located in the iliac artery.A 14x90/9fr wallstent uni was advanced for treatment.During the use of iliac vein stent, the stent could not be deployed and pushed out.However, it was found that the tip end of the stent strut was lifted up and it was bent, resulting in the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported.It was further reported that the target lesion was severely stenosed.

Manufacturer Narrative

Received a wallstent uni device.The stent was returned partially deployed by 10mm and some of the struts in the first row was pulled in a proximal direction.The stent was deployed without issue.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues.This concludes the product analysis.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: 12963316
• MDR Text Key: 281991280
• Report Number: 2134265-2021-15593
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026395979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/24/2021; 01/18/2022
• Supplement Dates FDA Received: 01/14/2022; 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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 Age: 65 YR
• Patient Sex: Female