MAUDE Adverse Event Report: ABBOTT BVS BIORESORBABLE VASCULAR SCAFFOLD

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 02/01/2018

Event Type  Injury  

Event Description

My father got abbott bio-degradable stent implanted about 2.5 years ago.He is experiencing health issues related to irregular blood pressure and heart beat from about last 6 months.We want to confirm if the issue is not due to the stent and what is the best course of action we can take at this point.

• Brand Name: BVS BIORESORBABLE VASCULAR SCAFFOLD
• Type of Device: BVS BIORESORBABLE VASCULAR SCAFFOLD
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 7411540
• MDR Text Key: 105152322
• Report Number: MW5076392
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 72 YR