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

Model Number 24657

Device Problems Entrapment of Device (1212); Difficult or Delayed Activation (2577); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 10/29/2019

Event Type  Injury  

Event Description

It was reported that the stent shortened and the delivery system became stuck on the wire during removal.A 7x120x130 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).During the procedure, the device was advanced antegrade into the femoral.During deployment, the stent did not flower like it would normally.The stent for shortened inside of the sfa and was not deployed to nominal length.The stent was 80mm instead of 120mm.Upon removal, the delivery system became stuck on the wire.It was eventually removed from the wire.Post dilatation was performed with a balloon and it looked better.Ultimately, a 7x80 innova self expanding stent was placed to cover the lesion with a good outcome.There were no patient complications reported.

• 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: 9340747
• MDR Text Key: 166962813
• Report Number: 2134265-2019-13986
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023156710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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
• Patient Outcome(s): Required Intervention