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

Model Number	24657
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that guidewire and catheter entrapment occurred.The target lesion was located in the superficial femoral artery.A.035 magic torque guidewire was used with a 7x100, 130cm eluvia self-expanding stent.During the procedure the guidewire became stuck within the stent delivery system and could not be removed.The magic torque guidewire and the eluvia stent delivery system were removed together as one unit.The procedure was then completed using a new guidewire and a 7x40mm eluvia stent.No patient complications were reported.
Event or Problem Description
It was reported that guidewire and catheter entrapment occurred.The target lesion was located in the superficial femoral artery.A.035 magic torque guidewire was used with a 7x100, 130cm eluvia self-expanding stent.During the procedure the guidewire became stuck within the stent delivery system and could not be removed.The magic torque guidewire and the eluvia stent delivery system were removed together as one unit.The procedure was then completed using a new guidewire and a 7x40mm eluvia stent.No patient complications were reported.
Additional Manufacturer Narrative
Device is combination product.Device evaluated by manufacturer: the device was returned for analysis consisted of an eluvia self-expanding stent system with a 0.035 guidewire stuck inside the device.Visual examination revealed that the outer sheath is separated at the nosecone and the middle sheath can be seen.There is a kink to the middle sheath at the nosecone.The pull rack is separated, and the proximal section is missing.There is a bend in the outer sheath at 79.5cm from the nosecone.Microscopic examination revealed no additional damages.The devices were placed in a water bath for several days and the guidewire was able to be removed.It was noticed that there are kinks to the guidewire so functional testing was perform with a test guidewire, which revealed the wire advanced through the inner liner and was able to pass through the device.Inspection of the remainder of the device, revealed 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: 9131412
• Report Number: 2134265-2019-11744
• Device Sequence Number: 2262519
• Product Code: NIU
• UDI-Device Identifier: 08714729876724
• UDI-Public: 08714729876724
• 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): 11/11/2019

1 Device 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: 05/12/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023046808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No