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	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an inadvertent deployment occurred.A 6x40x130 eluvia drug-eluting vascular stent system was selected for a peripheral stenting procedure in the superficial femoral artery (sfa).During the procedure, the delivery system would not track over the non-bsc guidewire.It was possible that the wire kinked.The eluvia device was removed from the patient with the stent fully intact.The yellow safety tab had been removed from the thumbwheel and the stent was accidentally deployed on the back table.The procedure was completed with a non-bsc stent.The patient was fine and there were no complications.
Additional 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 a kink on the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are is no longer in the manufactured position.The stent appears to have been deployed and did not return for product analysis.Per product specification, a 0.035" test guide wire was inserted into the device and was unable to pass through.The device was x-rayed, and no abnormalities were noticed at the area where the wire had difficulty passing.Further functional testing of the device was completed by again inserting a 0.035" test guidewire into the device.With some force the guidewire was able to pass through.Resistance was still felt so the device was disassembled to further investigate.The handle was opened, and the clip was cut off from the inner liner.The kink at the nosecone also made the proximal inner and inner liner kinked.The proximal inner was unable to be moved because of the kink so the proximal inner and inner liner was cut distal of the kink.The test guidewire was inserted into the proximal inner to locate the area of resistance.Microscopic examination of the area showed that the inner liner was kinked.Inspection of the remainder of the device, revealed no other damage or irregularities.The eluvia dfu includes the following related to issue: "do not remove the thumbwheel lock prior to deployment.Premature removal of the thumbwheel lock may result in an unintended deployment of the stent." it appears possible that the reported use contrary to instructions in the dfu contributed to the reported inadvertent deployment.
Event or Problem Description
It was reported that an inadvertent deployment occurred.A 6x40x130 eluvia drug-eluting vascular stent system was selected for a peripheral stenting procedure in the superficial femoral artery (sfa).During the procedure, the delivery system would not track over the non-bsc guidewire.It was possible that the wire kinked.The eluvia device was removed from the patient with the stent fully intact.The yellow safety tab had been removed from the thumbwheel and the stent was accidentally deployed on the back table.The procedure was completed with a non-bsc stent.The patient was fine and there were no 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: 9191458
• Report Number: 2134265-2019-12431
• Device Sequence Number: 2599506
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/06/2019

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: 04/12/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0022912969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERSACORE GUIDEWIRE; VERSACORE GUIDEWIRE