MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  Injury  

Event Description

Elderly male with severe aortic stenosis.Procedure: transcatheter aortic valve replacement (tavr).Procedure completed-when the delivery device was being retracted, the nose cone broke off inside of the patients right femoral artery.Urgent vascular consult warranted an emergent exploration and removal of cone and balloon, followed with repair.Patient discharged 3 post op day without further complications.Vascular consult: required additional procedure- exploration and evacuation of cone and balloon anesthesia admission and 3 night stay.Op note, vascular surgeon- dissection was then carried down carefully to the common femoral artery using combination of electrocautery and sharp dissection once the common femoral artery had been reached it was carefully dissected free proximally and distally and potts vessels were placed around the common femoral artery proximally profunda femoris artery and the superficial femoral artery.These were all noted to be extremely calcified.Patient received a bolus of iv heparin.Careful dissection along the wire was performed and the device and attached balloon were carefully identified and removed.Wound was copiously irrigated with antibiotic solution and surgical snow placed over the endarterectomy site.Wound closure was performed in layers with 3-0 pds bringing the reticular together with running suture with 3 different layers followed by 4-0 monocryl and dermabond and a sterile silver dressing.Patient was discharged recovery area in a stable condition with operable pedal signals and a pink foot.Manufacturer response for introducer, catheter, edwards esheath+ introducer set (per site reporter).Unknown.Manufacturer response for prosthesis, mitral valve, percutaneously delivered, sapien 3 ultra system (per site reporter).Aware.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14352763
• MDR Text Key: 291361949
• Report Number: 14352763
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240127(10)64198525
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64198525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 31755 DA
• Patient Sex: Male
• Patient Weight: 75 KG