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 Codes	Difficult to Insert (1316); Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination device.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6x40x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) intervention.During the procedure, the device was loaded on a.035, 180 cm guidewire.The eluvia device was not flushed and the yellow stylet was not removed from the back.While loading on the wire, the wire did not come out the back.The eluvia device was taken off the wire and was not deployed.The clip remained on.It was noted that the tip was partially deployed after the eluvia was taken off the wire.There were no patient complications reported.The procedure was completed with a different device.
Additional Manufacturer Narrative
Device is a combination device.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 yellow thumbwheel lock and flushing luer was still in the manufactured location.The thumbwheel lock appeared to be on backwards.The luer was pulled out and the tube appeared to be twisted.The pull rack was still in the manufactured position.There were kinks on the outer sheath at the nosecone, 59.6cm, and 59.8cm from the nosecone.There was a kink on the middle sheath 3.3cm from the distal end of the middle sheath.The stent was partially deployed approximately 8mm from the distal end of the middle sheath.There was blood present inside the middle sheath and on the stent.Microscopic examination did not reveal any additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6x40x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) intervention.During the procedure, the device was loaded on a.035, 180 cm guidewire.The eluvia device was not flushed and the yellow stylet was not removed from the back.While loading on the wire, the wire did not come out the back.The eluvia device was taken off the wire and was not deployed.The clip remained on.It was noted that the tip was partially deployed after the eluvia was taken off the wire.There were no patient complications reported.The procedure was completed with a different device.

• 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: 8437032
• Report Number: 2134265-2019-02695
• Device Sequence Number: 2249846
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0022587535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1