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

Model Number 24653

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of an eluvia self-expanding stent system with a flimsy 0.035-inch hydrophilic guidewire stuck inside.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual and microscopic examination revealed no damages.The handle was x-ray, and the proximal inner was prolapsed.The stent appeared to have been deployed and did not return for analysis.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the reported deployment issue and stent deformation.

Event Description

It was reported that the stent partially deployed and stretched.A 6x120mm, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty (pta) and stenting procedure in the moderately tortuous superficial femoral artery (sfa).There was a deployment failure.A strong force was required in order to rotate the thumbwheel.The stent was ultimately placed but stretching occurred.The procedure was completed.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: 18177403
• MDR Text Key: 328628127
• Report Number: 2124215-2023-64640
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029839763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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