—#174656

Product

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

FDA product code: NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P140031S074
Affected lot / code info: All Lots

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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,

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-07-09
Posted by FDA: 2019-08-21
Terminated: 2020-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174656. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.