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

Model Number 24653

Device Problem Fracture (1260)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a stent fracture occurred.An eluvia stent was selected for a procedure in the superficial femoral artery.Patient anatomy conditions revealed moderate calcification and tortuosity.During the procedure, it was noted that the eluvia stent was fractured.A viabahn stent was placed inside the eluvia to treat the fracture.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter city, initial reporter state: (b)(6).Device eval by manufacturer: the complaint device was not returned to boston scientific.However, media from the clinical procedure was provided by the customer.Analysis of the provided media confirmed the reported clinical observation of a stent fracture.

Event Description

It was reported that a stent fracture occurred.An eluvia stent was selected for a procedure in the superficial femoral artery.Patient anatomy conditions revealed moderate calcification and tortuosity.During the procedure, it was noted that the eluvia stent was fractured.A viabahn stent was placed inside the eluvia to treat the fracture.There were no patient complications reported.

• 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 SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12961575
• MDR Text Key: 281992141
• Report Number: 2134265-2021-15591
• 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: 01/07/2022

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 Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1