MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23

Device Problems Material Rupture (1546); Failure to Align (2522); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)

Patient Problems Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2018-04981 and 2015691-2018-04983.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, there was no allegation or indication a device malfunction contributed to this adverse event.  investigation results indicate that the reanimation and/or the guidewire was the cause for the effusion 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)(6), 6 years and seven month post implant of a 23mm sapien xt valve, the valve was degenerated (stenotic).Therefore a valve in valve was planned with a 23mm sapien 3 valve.While placing the guidewire, severe difficulties were encountered to cross the stenotic xt valve.Afterwards, during valvuloplasty, the 20mm edwards bav catheter balloon burst due to severe calcification.The catheter was able to be removed through the sheath without issues.However, due to free ai that was caused by the bav, the patients pressure dropped and cpr started.The patient had a severely tortuous aorta and difficulties were encountered during valve alignment.Valve diving was seen and it was not possible to correctly align the valve despite releasing tension several times.At the end, it was managed to get the valve between the markers with a gap of approx.3mm to the marker.With that it was attempted to deploy the valve.During deployment, the valve initially only opened distally but it was managed to anchor the valve in the annulus and fully deploy it.In control tee a pericardial effusion was then seen.It was assumed that the reanimation and/or the guidewire was the cause for the effusion.Catecholamines were administered and the effusion was punctured.The patient¿s pressure started to increase and after 10min the patient was stable again and transferred to icu.No ct evaluation was possible prior to valve implantation as the patient had renal failure.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8121820
• MDR Text Key: 129094221
• Report Number: 2015691-2018-04986
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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: 03/13/2020
• Device Model Number: 9610TF23
• Device Lot Number: 61304875
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/01/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR