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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9750CM26
Device Problems Failure to Advance (2524); Material Deformation (2976); Material Protrusion/Extrusion (2979)
Patient Problem Perforation (2001)
Event Date 02/15/2022
Event Type  Injury  
Event Description
Elderly male with history of severe aortic stenosis.Procedure: transcatheter aortic valve replacement (tavr) with an edwards 26 mm s3 valve via left axillary artery access.During tavr, via the left subclavian, edwards 14 fr sheath was "kinked" in the patient which caused the valve to not be able to go down the sheath.The valve then tore the sheath and had a point sticking out of the sheath casing which caused the perforation in the axillary artery.The system was removed, and a new system inserted with success.A 6x29n mm vbx covered stent repaired/sealed the perforated artery.Outcome: additional surgery- repair graft.Overnight stay.Patient discharged next day.Patient had poor access from the groins and therefore a left axillary artery approach was planned.2nd procedure: a small access was taken from the right groin.Right ventricular pacing wire was placed and tested.A pigtail was placed in the aortic root and the proper coplanar angle determined.Main access was taken through the left axillary artery.A straight wire was placed across the aortic valve into the left ventricle and then exchanged for a safari wire.When all was in readiness, the delivery system was placed on the wire and passed into the axillary artery.In one position, it was very difficult to advance and therefore it was removed and examined.It did appear that a strut of the valve had torn through the sheath and a small part of it was protruding.It was felt that the axillary artery may have sustained an injury from this.Therefore, an entirely new delivery system was used for the new valve.This was passed through the axillary artery without incident and then across the valve.It was deployed during a period of rapid pacing.It deployed well and had low gradients and no paravalvular leak.This was felt to be satisfactory.D/c summary: echocardiogram done this morning reviewed by doctor and shows normally functioning bioprosthetic valve with no significant pericardial effusion.He is stable for discharge home at this time.Will place patient on 1 week course of antibiotics due to wound on back.Discharge instructions, restrictions, wound care, and medication changes discussed with the patient at length and all questions were answered.He will be seen back in the structural heart clinic in approximately 30 days with echocardiogram prior to office visit.Manufacturer response for introducer, catheter, edwards esheath introducer set (per site reporter): will investigate.Manufacturer response for prosthesis, aortic valve, percutaneously delivered, edwards sapien 3 ultra transcatheter heart valve (per site reporter): will investigate.Manufacturer response for prosthesis, aortic valve, percutaneously delivered, sapien 3 ultra system (per site reporter): will investigate.
 
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Brand Name
SAPIEN 3 ULTRA SYSTEM
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key13677693
MDR Text Key286644297
Report Number13677693
Device Sequence Number1
Product Code NPT
UDI-Device Identifier00690103207835
UDI-Public(01)00690103207835(17)230526(10)63804344
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9750CM26
Device Catalogue Number9750CM26A
Device Lot Number63804344
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2022
Event Location Hospital
Date Report to Manufacturer03/07/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age26280 DA
Patient SexMale
Patient Weight85 KG
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