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

Model Number 7.0X100X135

Device Problems Difficult to Remove (1528); Activation Problem (4042)

Patient Problem Tissue Damage (2104)

Event Date 02/06/2020

Event Type  Injury  

Event Description

Stent did not deploy properly, physician was going to remove, he was unable to remove as the stent ruts and platform caught of plaque.Leg had a large amount of plaque.Vascular surgeon came and removed the stent from the illiac bifurcation.Cut down was done in order to retrieve the stent.

• Brand Name: ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9834868
• MDR Text Key: 183914251
• Report Number: MW5093763
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2020

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 Expiration Date: 05/31/2020
• Device Model Number: 7.0X100X135
• Device Catalogue Number: 1012532-100
• Device Lot Number: 7060161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 69