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

Model Number 24653

Device Problem Premature Activation (1484)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed.A 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure to treat thrombosis and occlusion in the superficial femoral artery (sfa).The stent was inserted over a guidewire.Before advancing the stent through the introducer sheath and into the patient, the physician decided to exchange the guidewire.While retracting the stent delivery system, the stent partially deployed over the guidewire and the table.The stent never came in contact with the patient.Another guidewire and another 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system were inserted, and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: 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 to the outer sheath at the nosecone.The stent was missing and was not returned for analysis.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

It was reported that the stent inadvertently deployed.A 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure to treat thrombosis and occlusion in the superficial femoral artery (sfa).The stent was inserted over a guidewire.Before advancing the stent through the introducer sheath and into the patient, the physician decided to exchange the guidewire.While retracting the stent delivery system, the stent partially deployed over the guidewire and the table.The stent never came in contact with the patient.Another guidewire and another 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system were inserted, and the procedure was completed.No patient complications were 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
• MDR Report Key: 10949399
• MDR Text Key: 219901478
• Report Number: 2134265-2020-16932
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024566021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1