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

Model Number 26280

Device Problems Positioning Failure (1158); Premature Activation (1484); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

Reportable based on additional information received on 08oct2019.It was reported that stent damage occurred.The target lesion was located in the iliac vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.When advancing the device, resistance was felt from the sheath and the stent could not be deployed.The device was removed from the patient without any portion of the stent exposed, but when the physician attempted to check the issue of the stent after removal, the stent was deployed by accident and the stent struts was noted to be kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was received with the stent fully deployed from the device.The stent was not returned for analysis.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination identified a severe kink on the inner shaft located approximately 45mm distal of the stent holder.The kink to the inner shaft is located where the stent was mounted on the delivery system.The blue outer shaft of the device was also severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

Reportable based on additional information received on 08oct2019.It was reported that stent damage occurred.The target lesion was located in the iliac vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.When advancing the device, resistance was felt from the sheath and the stent could not be deployed.The device was removed from the patient without any portion of the stent exposed, but when the physician attempted to check the issue of the stent after removal, the stent was deployed by accident and the stent struts was noted to be kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80-90 percent stenosed.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9266022
• MDR Text Key: 167875823
• Report Number: 2134265-2019-13243
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• Combination Product (y/n): N
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023650788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1