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	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.The target lesion was located in the right superficial femoral artery (sfa).A 6 x 60 x 130 cm eluvia drug-eluting vascular stent system was selected for use.Angioplasty was performed prior to stent placement.Two eluvia 6 x 120 stents were placed successfully over a non-bsc guidewire.The guidewire had a slight kink.In an attempt to load the 6 x 6 x 130 eluvia stent over the guidewire past the kink location, the stent began to deploy over the wire prior to advancing through the sheath.The lock was never taken off of the thumbwheel.The thumbwheel nor the pull grip were used.The stent was still outside the patients body and never entered the patient.The stent delivery system was removed from the guidewire without incidence.The kinked wire was replaced with a new wire and the procedure was completed with a 6 x 40 eluvia stent.There were no patient complications.

• 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: 10408228
• Report Number: 2134265-2020-11080
• Device Sequence Number: 19474698
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 08/14/2020

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: 09/29/2021
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0024626711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: VERSACORE
• Patient Age: 78 YR