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

Model Number 26650

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was received with the stent partially deployed from the delivery system.The stent could not be deployed as indicated in the ifu due to a complete break in the outer shaft of the device.For investigation purposes the investigator was able to deploy the stent by gripping the damaged section shaft.No resistance was encountered during deployment.The stent was visually and microscopically examined, and no damage or issues were identified.A visual and microscopic investigation identified no issues with the stent cup or stent holder that could have contributed to the complaint incident.The imprinted stent impression was clearly visible on the stent holder.A visual and tactile inspection identified a complete break of the shaft of the device located approximately 50mm distal of the distal end of the main valve of the device.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 15sep2020.It was reported that shaft kink occurred.The target lesion was located in the bile duct.After placing a 035x145 non-bsc guide, a 10 x 68mm x 75cm wallstent-uni endoprosthesis was advanced for treatment.Resistance from the pusher was encountered upon maneuvering for release.After several attempts to release the stent, the shaft of the stent got kinked at about 5 cm distal to the pusher.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a partially deployed stent.

• 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: 10580755
• MDR Text Key: 208354120
• Report Number: 2134265-2020-13185
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: UY
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: 26650
• Device Catalogue Number: 26650
• Device Lot Number: 0024807221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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
• Treatment: GUIDE CATHETER: 035X145 ROADRUNNER