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

Model Number 24653

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a guidewire became caught on the stent strut.A 6x120x130 eluvia self-expanding stent was selected for use.The target lesion was severely calcified and entirely occluded and was located in the superficial femoral artery (sfa).The sfa was approached via an ipsilateral antegrade approach.A 0.014 non-bsc guidewire was passed through the occluded lesion, and the lesion was pre-dilated with a balloon.The eluvia was then successfully deployed.Mild resistance was noted during successful removal of the stent delivery system.Severe resistance was felt while removing the guidewire.Fluoroscopy confirmed the resistance was due to the guidewire entangled with the implanted eluvia stent.The stent strut was bent inwards.The guidewire could not be removed, and surgical intervention the next day was required to remove the guidewire.The eluvia stent remains implanted.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10537079
• MDR Text Key: 207043587
• Report Number: 2134265-2020-12735
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0025173981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: COMMEND (CENTURY CORPORATION); INTRODUCER SHEATH: TERUMO DESTINATION 6F
• Patient Outcome(s): Required Intervention