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

Model Number 20300

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the stent inadvertently deployed.A 6x80x120 epic stent was selected for use.During unpacking, while flushing the device, it was noticed that the proximal portion 2-4mm of the stent was open and the remaining stent was still crimped.The safety lock was not removed.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

E1 - initial reporter address 1:(b)(6).

Event Description

It was reported that the stent inadvertently deployed.A 6x80x120 epic stent was selected for use.During unpacking, while flushing the device, it was noticed that the proximal portion 2-4mm of the stent was open and the remaining stent was still crimped.The safety lock was not removed.The procedure was completed with a different device.There were no patient complications reported.However, it was further reported that stent was not partially deployed and was in fully reconstrained state.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6) 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 is partially deployed approximately 3mm from the distal end of the sheath.Microscopic examination revealed that the stent is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the stent inadvertently deployed.A 6x80x120 epic stent was selected for use.During unpacking, while flushing the device, it was noticed that the proximal portion 2-4mm of the stent was open and the remaining stent was still crimped.The safety lock was not removed.The procedure was completed with a different device.There were no patient complications reported.However, it was further reported that stent was not partially deployed and was in fully reconstrained state.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10514594
• MDR Text Key: 206332012
• Report Number: 2134265-2020-12513
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2020

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: 09/03/2022
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0024377542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 10/06/2020
• Supplement Dates FDA Received: 09/21/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 65