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 09/20/2019

Event Type  malfunction  

Event Description

It was reported that stent inadvertent deployment occurred.A 6x80x75 eluvia self expanding stent was selected for a procedure.During preparation, while flushing the yellow luer with heparinized saline, the stent deployed outside the patient's body.The yellow safety cap was still positioned on the thumbwheel.There were no patient complications reported.

Event Description

It was reported that stent inadvertent deployment occurred.A 6x80x75 eluvia self expanding stent was selected for a procedure.During preparation, while flushing the yellow luer with heparinized saline, the stent deployed outside the patient's body.The yellow safety cap was still positioned on the thumbwheel.There were no patient complications reported.It was further reported that the procedure was completed with a different stent.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia 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 partially deployed approximately 7mm from the distal end of the middle sheath.There was a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that stent inadvertent deployment occurred.A 6x80x75 eluvia self expanding stent was selected for a procedure.During preparation, while flushing the yellow luer with heparinized saline, the stent deployed outside the patient's body.The yellow safety cap was still positioned on the thumbwheel.There were no patient complications reported.It was further reported that the procedure was completed with a different stent.

• 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: 9162935
• MDR Text Key: 161775754
• Report Number: 2134265-2019-12039
• 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,Followup
• Report Date: 11/20/2019

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 Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023656308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/13/2019; 11/20/2019
• Supplement Dates FDA Received: 10/16/2019; 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1