MAUDE Adverse Event Report: EV3, INC. EVERFLEX ; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number REF EVD3506040120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Chest Pain (1776); No Code Available (3191)

Event Date 12/30/2016

Event Type  Injury  

Event Description

Pt has had an array of symptoms such as cellulitis, bone infections, and intermittent chest pains such that it felt that something was broken in there, since the first implant.Pt states that she had two toes amputated as a result of the implant and she has also had a staph infection of her toes.Pt has also said that she might have to lose her leg.

• Brand Name: EVERFLEX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3, INC.
• MDR Report Key: 8703881
• MDR Text Key: 148332849
• Report Number: MW5087401
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: REF EVD3506040120
• Device Lot Number: A314036
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 54