Class 1 Device Recall Edwards Sapien 3 Ultra Delivery System

• Date Initiated by Firm: July 09, 2019
• Date Posted: August 21, 2019
• Recall Status: Terminated on September 15, 2020
• Recall Number: Z-2224-2019
• Recall Event ID: 83293
• PMA Number: P140031S074
• Product Classification: Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
• Product: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: Parita Davda; 949-250-1572
• Manufacturer Reason for Recall: The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
• FDA Determined Cause: Other
• Action: On July 09, 2019 the firm sent an Urgent Field Safety Notice REF: FCA - 141 to consignees via FEDEx Priority Overnight. The Urgent Field Safety Notice informs consignees of the following: 1. When deploying the valve, inflate the balloon slowly and continuously throughout deployment. Hold for 3 seconds at full inflation. " The delivery system requires a prescribed volume for THV deployment and proper function (11 mL, 17 mL, 23 mL, 33 mL). 2. The following warning will also be added to the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System IFU: " Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention. 3. If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following technique: A. Close stopcock to the delivery system and remove inflation device from stopcock. B. Continuously twist the handle in a clockwise direction (full 360 degree rotations) while gently pulling back the delivery system into the sheath tip. Verify delivery system tip has entered the sheath tip under fluoroscopy. C. DO NOT FORCE if resistance is met near or at the sheath tip. Forcing retrieval when meeting resistance could result in additional balloon material tearing or tip dislodgement. Consider utilizing other interventional techniques for retrieval (e.g. a snare). D. If successful in pulling the entire balloon into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position. DO NOT attempt to pull the delivery system through the remaining length of the sheath. E. If resistance is still encountered, convert to surgery for device removal. Based on medical assessment of the size, tortuousity,
• Quantity in Commerce: 362 units
• Distribution: US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NPT