MAUDE Adverse Event Report: ABBOTT ABSORB GT1 - BIORESORBABLE VASCULAR SCAFFOLD - 3.0MM > 28MM

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

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 08/21/2017

Event Type  Injury  

Event Description

After the absorb gt1 implanting procedure 2 months ago, i feel a chest pain and shortness of breath to seek, i would like to know if that is normal or what shall i do regarding the pain.

• Brand Name: ABSORB GT1 - BIORESORBABLE VASCULAR SCAFFOLD - 3.0MM > 28MM
• Type of Device: ABSORB GT1 - BIORESORBABLE VASCULAR SCAFFOLD - 3.0MM > 28MM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 6812830
• MDR Text Key: 83542530
• Report Number: MW5071753
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: AM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 88