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

Model Number 24657

Device Problems Fracture (1260); Difficult to Remove (1528); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system was visually examined, which revealed the stent was partially deployed 5mm from the middle sheath.The stent was separated and measured approximately 13.4cm.There were multiple kinks to the outer sheath and middle sheath.The pull rack was separated at the handle.Microscopic examination revealed no additional damages.X-ray examination of the handle found that the middle sheath was separated from the retainer.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the stent fracture.

Event Description

It was reported that the stent fractured, requiring an additional stent to be placed.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery stenting procedure.The previously placed stent exhibited in-stent restenosis; therefore, the new stent was being placed in the moderately calcified, mildly tortuous target lesion.After deployment of this stent inside the previously placed stent, the physician felt resistance when trying to remove the delivery system.When it was removed, a piece of stent was noted on the deployment device.It was noted that the deployment device or the stent may have gotten caught on the originally placed stent.Another stent was placed to cover the stents to resolve the issue.There were no patient complications.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17461820
• MDR Text Key: 320421421
• Report Number: 2124215-2023-36728
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

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 Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030189265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention