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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX20
Device Problems Valve; Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2017
Event Type  Death  
Manufacturer Narrative

Per the instructions for use (ifu) cardiovascular injury, such as perforation dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure. According to the thv training manuals, risk factors for aortic dissection, hematoma or annular rupture during the tavr procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification and narrow calcified stj. In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors. The sapien valve relies on native valve calcium to securely anchor to the annulus. Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury. At times the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve and procedural success. In this case, the cause for the annular rupture was likely caused by the patient¿s severely calcified native annulus, severely calcified native leaflets and moderately calcified native aortic root. 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 by our affiliates in (b)(4), after implant of a 20 mm sapien 3 valve in the aortic position, pvl was observed and the valve was post dilated. Three dilatations were performed. The final angio showed no pvl. After a few minutes the patient¿s pressure dropped and pericardial effusion with tamponade was observed on tee. A pericardial drain was performed, but the patient¿s hemodynamics were still unstable. The patient was taken to the or and the sapien 3 valve was explanted and a surgical valve was implanted. The patient expired in the or. The patient¿s native annulus was 318 mm2 by ct. The native annulus was severely calcified, native leaflets were severely calcified and the native aortic root was moderately calcified. As per medical opinion, annular perforation by the patient¿s native calcification may have contributed to the event. The patient¿s death was attributed to her fragility and age.

 
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Brand NameEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Type of DeviceAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
frances preston
1 edwards way
irvine , CA 92614
9492505190
MDR Report Key6821547
Report Number2015691-2017-02628
Device Sequence Number1
Product CodeNPT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/10/2019
Device MODEL Number9600TFX20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/24/2017
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: 08/25/2017 Patient Sequence Number: 1
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