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

Model Number 24653

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: 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 that the stent is partially deployed 15mm from the distal end of the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock for the thumbwheel is missing.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the device was unable to cross a previously placed stent.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified right superficial femoral artery (sfa).During placement of the 6x120, 130cm eluvia drug-eluting vascular stent system, the stent was unable to cross the previously placed 6x12 eluvia and got stuck.The shaft kinked when it was pushed a little hard.A new eluvia was used to complete the procedure.No patient complications were reported.However, device analysis revealed the stent was partially deployed.

• 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: 11986293
• MDR Text Key: 255942670
• Report Number: 2134265-2021-07586
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0026060984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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