MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

It was reported that the stent prematurely deployed.A 6x80, 130 cm eluvia self expanding stent was selected for use for a lower angioplasty procedure.A cross over approach was being utilized and as the physician was pushing the stent past a tight bifurcation, the stent seemed to have caught on the calcified lesion, and started to prematurely deploy despite the safety lock being in place.The physician then deployed the remainder of the stent without issue at the target lesion.There were no patient complications reported.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7991603
• MDR Text Key: 124665107
• Report Number: 2134265-2018-61581
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2018

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: 08/05/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021753956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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