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 04/25/2022

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed and stretched.The target lesion was located in the superficial femoral artery (sfa).A 7x120, 130cm eluvia drug-eluting vascular stent system was selected for an endovascular therapy (evt) procedure.The lesion was predilated.During the procedure, the thumbwheel was completely rotated; however, the stent did not fully deploy.There was a grinding tone when the thumbwheel was being rotated.When the entire delivery shaft was pulled, the stent deployed and stretched approximately 3cm.There were no patient complications.

Event Description

It was reported that the stent partially deployed and stretched.The target lesion was located in the superficial femoral artery (sfa).A 7x120, 130cm eluvia drug-eluting vascular stent system was selected for an endovascular therapy (evt) procedure.The lesion was predilated.During the procedure, the thumbwheel was completely rotated; however, the stent did not fully deploy.There was a grinding tone when the thumbwheel was being rotated.When the entire delivery shaft was pulled, the stent deployed and stretched approximately 3cm.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the 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 examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The handle was disassembled, and the proximal inner is prolapsed.The stent appears to have been deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 14459870
• MDR Text Key: 292371923
• Report Number: 2134265-2022-05660
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028059665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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