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 Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Event Description

It was reported that the device slightly inadvertently deployed.A 6x120, 130 cm eluvia self expanding stent was selected for a stenting procedure.During device unpacking, it was noticed that the stent was a little out of the sheath.A different device was used to complete the procedure.There were no patient complications.

Event Description

It was reported that the device slightly inadvertently deployed.A 6x120, 130 cm eluvia self expanding stent was selected for a stenting procedure.During device unpacking, it was noticed that the stent was a little out of the sheath.A different device was used to complete the procedure.There were no patient complications.Returned product consisted of an eluvia self-expanding stent system with the thumbwheel lock still attached.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink at the nosecone.The stent was returned in the device and partially deployed 6.5mm from the distal end of the mid-shaft.The blue handle was still in the start position prior to functional testing.The thumbwheel was rotated and the stent started to deploy.The device functioned as designed.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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
• MDR Report Key: 7966764
• MDR Text Key: 123804620
• Report Number: 2134265-2018-61947
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• 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: 11/15/2018

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: 12/16/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022326837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 11/15/2018
• Patient Sequence Number: 1