MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC

Model Number 20300

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent was deployed and no longer inside the sheath.The stent was damaged.There are multiple kinks along the inner liner.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the deployment issues.

Event Description

Reportable based on device analysis completed on 10dec2020.It was reported that stent failure to deploy.The more than 70% stenosed target lesion was located in the mildly tortuous and almost non-calcified right hepatic vein.Physician was performing transjugular intrahepatic portosystemic shunt procedure using a 0.035" wire and 10f sheath.Lesion was predilated using a 8 x 60 mustang balloon catheter.A 10x100x120 epic stent was advanced for treatment, however during deployment and pulling the stent delivery lever back, the stent did not deploy.The physician removed the stent outside completely and again tried to pull pack the stent delivery system upon which the stent deployed 25% of its total length.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a stent damage.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• 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: 11020404
• MDR Text Key: 222020986
• Report Number: 2134265-2020-17978
• Device Sequence Number: 1
• Product Code: NIO
• 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: 12/16/2020

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: 11/24/2022
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0024829385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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
• Patient Age: 34 YR