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

Model Number 9600TFX26

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

Patient Problem Rupture (2208)

Event Date 03/08/2017

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, with the limited information the annular rupture was most likely caused by the mechanisms above.It is also likely related to the presence of heavy calcification at the native leaflets.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 the edwards canadian affiliate, a 26 mm sapien 3 valve was prepped to be implanted in the aortic position through right trans-femoral approach using the cutdown technique.The 14fr esheath was inserted, a bav was performed successfully prior to inserting the commander system.The deployment was successful and post echo images revealed good positioning with no pvl.Approximately 5 minutes post implant, while proceeding to femoral closure, a significant drop in pressure was noted as well as a pericardial effusion.A thoracotomy was immediately performed.The patient was stabilized and sent to ccu to recover following the procedure.Later during the day the patient was taken to the operation room as bleeding reoccurred.Initially it was believed the wire had punctured the lv but it was later confirmed the patient suffered an annular rupture during tavi.The patient unfortunately passed away.It is believed the cause of the annular rupture was probably heavy calcification and its interaction with the 26mm sapien 3 valve.With the annular area measuring around 440mm2, this was felt to be appropriate for a 26mm sapien 3 thv.It was hypothesized by the physicians that perhaps a 23mm sapien 3 might have been better to avoid annulus rupture.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC 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 Key: 6439627
• MDR Text Key: 71031981
• Report Number: 2015691-2017-00815
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2017

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: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 9600TFX26
• Device Lot Number: 5170480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/28/2017
• Date Device Manufactured: 10/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 63