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

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

  • 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
 

EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX23A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 02/12/2021
Event Type  Injury  
Manufacturer Narrative
The instructions for use (ifu) lists cardiovascular injury that may require intervention (including perforation or dissection of vessels, ventricle, myocardium or valvular structures, annular tear or rupture) as a potential risk associated with the overall tvr procedure. Cardiac aneurysms have been reported as a rare complication following surgical or transcatheter valve replacement. This type of defect in the cardiac tissues or aortic wall can result from trauma during percutaneous valve implantation or additional in-valve balloon dilation on a heavily calcified native valve. Percutaneous/surgical intervention may be required. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. The exact cause of the aneurysm post procedure is unknown, however many be due to patient/procedural factors. The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. No corrective or preventative actions are required.
 
Event Description
As reported, approximately 3 days post transcatheter pulmonic valve replacement (tpvr) with a 23mm sapien 3 valve, an aneurysm was observed, and a covered stent was implanted to repair the pulmonary artery aneurysm. Next, a 2nd valve was placed within the covered stent. The patient is stable post procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Type of DevicePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
9492506385
MDR Report Key11440951
MDR Text Key242793253
Report Number2015691-2021-01755
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/21/2021
Device Model Number9600TFX23A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/08/2021 Patient Sequence Number: 1
-
-