MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO; STENT, ILIAC

Model Number REF 1012534-100

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: ABSOLUTE PRO
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 8703881
• MDR Text Key: 148332849
• Report Number: MW5087401
• Device Sequence Number: 2
• Product Code: NIO
• 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 1012534-100
• Device Lot Number: 6071961
• 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