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

Model Number 20300

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 09/14/2019

Event Type  Injury  

Event Description

It was reported that the stent fractured during post-dilation resulting in a leak in the vessel.The target lesion was in the biliary duct.The lesion measured 100mm in length with a 10mm vessel diameter without a significant bend.Vascular access was gained via the femoral artery.Pre-dilation was not performed.A 10x100x120mm epic self expanding stent was selected for treatment.During deployment the stent would not fully expand.A 10x40mm non bsc balloon was used for post dilation.During balloon inflation within normal dilation range, the epic stent struts broke.Angiogram was taken and reveled a leak in the biliary duct at the location of the broken stent struts.Subsequently, a 10x80 epic stent was placed inside the broken epic stent.No further patient complications were reported, and the patient was fine.

Event Description

It was reported that the stent fractured during post-dilation resulting in a leak in the vessel.The target lesion was in the biliary duct.The lesion measured 100mm in length with a 10mm vessel diameter without a significant bend.Vascular access was gained via the femoral artery.Pre-dilation was not performed.A 10x100x120mm epic self expanding stent was selected for treatment.During deployment the stent would not fully expand.A 10x40mm non bsc balloon was used for post dilation.During balloon inflation within normal dilation range, the epic stent struts broke.Angiogram was taken and reveled a leak in the biliary duct at the location of the broken stent struts.Subsequently, a 10x80 epic stent was placed inside the broken epic stent.No further patient complications were reported, and the patient was fine.

Manufacturer Narrative

Correction to field d4: lot number.The lot number was initially reported as 0023109743.This device was implanted, and incorrectly marked to be returned.The returned device lot number was 0023109743 and the device analysis results do not match the reported event.The most likely lot number is 0022744072.Correction to field d4 expiration date and unique identifier (udi) #- removed date and udi #.Correction to field d10: device avail for evaluation changed to no.Correction to field h3: rfb device eval by mfr updated to not applicable.Correction to field h3: device return to manufacturer updated to no.Correction to field h4: device manufacture date- removed date.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9175118
• MDR Text Key: 161853802
• Report Number: 2134265-2019-12244
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0023109743
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR