MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES LLC EDWARDS SAPIEN 3 TRANSCATHETER TAVR HEART VALVE (THV); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600 TFX 29A

Device Problems Difficult or Delayed Positioning (1157); Activation Problem (4042)

Patient Problems Cardiac Arrest (1762); Death (1802); Cardiac Perforation (2513)

Event Date 02/02/2021

Event Type  Death  

Event Description

Attempted trans-axillary transcatheter aortic valve replacement (tavr) with edwards sapien 3 ultra valve: 29 mm surgical cutdown, left axillary artery.Procedure: patient was brought to the hybrid operating room for planned elective tavr.Anesthesia placed the patient under general anesthesia.Vascular surgery performed cut down of the left axillary artery.Systemic iv ufh was administered with goal act >250 seconds.Pigtail catheter was advanced over an 0.035" jwire and positioned it in the right-coronary cusp (rcc) through the right radial artery.Aortic root angiography was then performed in the implant angle in order to confirm a co-planar view.A 4 fr berenstein catheter was used to cross aortic valve with a 0.035 straight wire.Pre tavr lvedp was 12 mmhg.A safari wire was advanced into the left ventricle.The edwards sapien s3 valve delivery system was introduced, balloon was loaded into the valve frame, delivery was advanced down the ascending aorta.We then paused at the level of the av to test the tvp, confirmed good capture, and then advanced the sapien valve across the aortic valve, and positioned it optimally under aortic root angiography.We then deployed the valve under rapid rv pacing at 180 bpm with adjunctive aortic root angiography.Unfortunately, during valve deployment, the balloon "water-melon seeded" from the valve with mal-deployment of the edwards valve across the native aortic valve.An attempt at re-positioning the valve caused ventricular displacement of the apparatus and perforation of the lateral wall of the lv.Cpr was performed and cardiothoracic surgery performed and immediate sternotomy with identification of the perforation.Given the patient's baseline peripheral vascular disease, cerebrovascular disease, age, and other co-morbidities, discussion was done and the group consensus was that no further intervention was indicated and likelihood of recovery congruent with the patient's goals of care was unattainable.The patient expired and all surgical incisions were closed.Complications: lv lateral wall perforation cardiac arrest patient death.Fda safety report id# (b)(4).

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER TAVR HEART VALVE (THV)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFE SCIENCES LLC; irvine CA 92614
• MDR Report Key: 11384893
• MDR Text Key: 233996383
• Report Number: MW5099642
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: 00690103194364
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600 TFX 29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 91 YR
• Patient Weight: 75