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

Model Number 24653

Device Problem Entrapment of Device (1212)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: the returned eluvia self-expanding stent system was analyzed, as was an unknown 0.014 in.Guidewire that was stuck within the device.Visual examination revealed that the sheath was kinked at the nosecone.The outer sheath was separated and damaged 4 cm.From the nosecone.The middle sheath was separated 8.3 cm.From the nosecone.Lastly, the inner liner was separated 8.4 cm.From the nosecone.The handle was x-rayed, and the proximal inner was observed to be prolapsed.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.An eluvia 7mm-120mm/130 cm was selected for use in the superficial femoral artery.(b)(4).During withdrawal, there was resistance when the device was removed from the sheath after successful stent placement.As a result, the device was removed together with the guidewire.There were no adverse patient consequences reported.However, device analysis revealed the sheath was separated.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15423957
• MDR Text Key: 300467325
• Report Number: 2124215-2022-33551
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028701263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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