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

Model Number 24653

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the stent partially deployed.A 6mm x 120mm x 130cm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.During the procedure, the stent was partially released, but it was unable to continue releasing.There was no rotation.Therefore, the catheter was pulled back a little to pass through the stenosis part, and the stent was able to continue releasing.The procedure was completed with this device.No patient complications were reported, and the patient was stable following the procedure.

Manufacturer Narrative

A2: age at time of event: 18 years or older.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 pull rack was separated from the handle approximately 10.7cm from the knob.There was a kink to the inner liner 10.6cm from the tip.Microscopic examination revealed no additional damages.

Event Description

It was reported that the stent partially deployed.A 6mm x 120mm x 130cm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.During the procedure, the stent was partially released, but it was unable to continue releasing.There was no rotation.Therefore, the catheter was pulled back a little to pass through the stenosis part, and the stent was able to continue releasing.The procedure was completed with this device.No patient complications were reported, and the patient was stable following the procedure.

• 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: 14592397
• MDR Text Key: 293281482
• Report Number: 2134265-2022-06345
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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: 07/01/2022

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: 02/20/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0026928455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2021
• 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