MAUDE Adverse Event Report: ABBOTT ABSORB GT1; CORONARY STENT

Model Number ABSORB GT1 BVS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Respiratory Distress (2045)

Event Date 01/22/2018

Event Type  Injury  

Event Description

In (b)(6) 2017, i had the abbott gt1 bvs absorb stent placed in my heart, after 9 months the stent failed.In started getting chest pain and shortness of breath.I had to be restented on (b)(6) 2018.

• Brand Name: ABSORB GT1
• Type of Device: CORONARY STENT
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 7302389
• MDR Text Key: 101279098
• Report Number: MW5075563
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648013089
• UDI-Public: 0108717648013089
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ABSORB GT1 BVS
• Device Lot Number: 7021042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 95