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

Model Number 26650

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - 18 years or older.Device evaluated by mfr.: the device was returned for analysis.The device was received with the stent in position on the inner shaft.Deployment of the stent has been attempted but the stent has not dilated due to the braided inner lining of the outer shaft wrapped around it.The stent wires at the distal end of the stent were noted to be damaged and have penetrated through the braided inner lining which has detached from the blue outer shaft of the device.The stent cannot be deployed from the device.A visual and tactile inspection identified no issues with the tip of the device.The outer shaft and stainless steel shaft were found to be kinked at approximately 150mm distal of the main valve of the device.This type of damage is consistent with the excessive force being applied to the device, possible during the attempt to deploy the stent.No other issues were noted with the delivery system that could potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 12-oct-2020.It was reported that stent deployment failure occurred.Vascular access was obtained via the femoral artery.The target lesion was located in a moderately tortuous and mildly calcified vessel.A 10 x 94mm x 75cm wallstent-uni endoprosthesis was advanced for treatment but the stent did not open while deploying in the left duct.The device was removed and the procedure was completed with a different device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: WALLSTENT-UNI ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 10728365
• MDR Text Key: 212787323
• Report Number: 2134265-2020-14613
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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: 05/15/2022
• Device Model Number: 26650
• Device Catalogue Number: 26650
• Device Lot Number: 0025515891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• 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