Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
This recall has been terminated (originally issued August 21, 2019).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- July 9, 2019
- Posted
- August 21, 2019
- Terminated
- September 15, 2020
- Recall Number
- Z-2227-2019
- Quantity
- 1754
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
All Lots
Root Cause
Other
Action Taken
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,