• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT BVS BIORESORBABLE VASCULAR SCAFFOLD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT BVS BIORESORBABLE VASCULAR SCAFFOLD Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBVS BIORESORBABLE VASCULAR SCAFFOLD
Type of DeviceBVS BIORESORBABLE VASCULAR SCAFFOLD
Manufacturer (Section D)
ABBOTT
MDR Report Key7411540
MDR Text Key105152322
Report NumberMW5076392
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
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
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/09/2018 Patient Sequence Number: 1
-
-