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

Model Number	24657
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 6x40x130 eluvia drug-eluting vascular stent system was selected for use for an angioplasty and stenting procedure in the superficial femoral artery (sfa).During preparation, it was observed that the stent was just barely exposed at the tapered nose cone as if it was starting to deploy.However, the yellow safety was still intact on the deployment wheel.The stent was never introduced into the sheath or patient body.The procedure was completed with a different stent and there were no patient complications reported.
Event or Problem Description
It was reported that the stent inadvertently deployed.A 6x40x130 eluvia drug-eluting vascular stent system was selected for use for an angioplasty and stenting procedure in the superficial femoral artery (sfa).During preparation, it was observed that the stent was just barely exposed at the tapered nose cone as if it was starting to deploy.However, the yellow safety was still intact on the deployment wheel.The stent was never introduced into the sheath or patient body.The procedure was completed with a different stent and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 23020071.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the sheath at the nosecone.The stent is partially deployed 2mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured position.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10800790
• Report Number: 2134265-2020-15416
• Device Sequence Number: 16960649
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023020071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1