MAUDE Adverse Event Report: EDWARDS LIFESCIENCES UNKNOWN EDWARDS TRANSFEMORAL DELIVER SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number TF DELIVERY SYSTEM UNKNOWN

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

Patient Problem Blood Loss (2597)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Citation: kisacik, halil, et al."evaluation of acquired thrombocytopenia according to the balloon-expandable versus self-expandable valves in patients undergoing transcatheter aortic valve replacement." angiology (2020): 0003319720953048.The delivery system model and size is unknown.Possible delivery systems used include ¿ edwards retroflex 3 delivery system ¿ pma p110021, edwards novaflex+ delivery system ¿ pma p130009, or edwards commander delivery system ¿ pma p140031.Per the instructions for use (ifu) complications such as cardiovascular injury, perforation dissection of vessels, ventricle, myocardium or valvular structures, are known potential complications 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 3 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, there was no allegation or indication a device malfunction contributed to this event.Although the cause for ¿major bleed¿ events was not provided by the author and with limited information provided in the literature, patient factors/co-morbidities not provided in addition to the procedure itself, may have contributed to the reported complications and subsequent conversion to surgery.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 the edwards (b)(6) affiliate, medical article: "evaluation of acquired thrombocytopenia according to the balloon-expandable versus self-expandable valves in patients undergoing transcatheter aortic valve replacement" was reviewed.Data was pulled from 127 patients who underwent tavr.From them, 61 were implanted with the balloon expandable sapien valve in a single center between april 2013 and august 2019.Two major bleeding events were noted related to balloon expandable valves.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-15106 and 2015691-2020-15112.

• Brand Name: UNKNOWN EDWARDS TRANSFEMORAL DELIVER SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11041532
• MDR Text Key: 222660698
• Report Number: 2015691-2020-15110
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other