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

Model Number 24653

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that a stent fracture occurred the 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following the placement of two non-bsc stents, a 6x120mm eluvia stent was placed.A non-bsc balloon catheter was then used for post-dilation.The balloon catheter became caught during removal, but was able to be removed as it was.After the balloon was removed from the patient, a piece of stent was found on the balloon.Angiography was performed on the patient and confirmed no fragments were left inside the patient.The procedure was completed.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent.Visual examination revealed that the returned section appears to be part of an eluvia stent.The returned section is approximately 4mm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis suggests that the returned section does appear to be an eluvia stent.

Event Description

It was reported that a stent fracture occurred the 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following the placement of two non-bsc stents, a 6x120mm eluvia stent was placed.A non-bsc balloon catheter was then used for post-dilation.The balloon catheter became caught during removal, but was able to be removed as it was.After the balloon was removed from the patient, a piece of stent was found on the balloon.Angiography was performed on the patient and confirmed no fragments were left inside the patient.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; 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: 12814677
• MDR Text Key: 281013814
• Report Number: 2134265-2021-14291
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0026782641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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