MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC XENOGRAFT EDWARDS INTUITY ELITE AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT

Model Number 8300AB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Extubate (2402); Organ Dehiscence (2502)

Event Date 08/10/2019

Event Type  malfunction  

Event Description

Patient came into hospital diagnosed with severe aortic stenosis.He underwent catheterization showing normal coronaries and the valve could not be crossed.His ejection fraction was approximately 30%.Patient went to operation room for an edward intuity aortic valve replacement.Patient extubated a few days later, and subsequently re-intubated two days after being extubated.A day after re-intubation patient had echo which showed mild to moderate aortic valve regurgitation; aortic valve prosthesis is normal in appearance.Ejection fraction estimated at 40%.Patient started on amiodarone for a-fib.The next day patient noted to have cardiomegaly on ct.A few days later systolic murmur noted.Cardiologist reviewed previous echo with colleague, noted "paravalvular regurg appears to be significant, prosthesis projecting in out flow." subsequently, another echo done and showed: "rocking of the aortic valve prosthesis and severe paravalvular aortic regurgitation." medical doctor notes: "tee echo without dehiscence of aortic valve prosthesis; patient to surgery; paravalvular leak with dehiscence." in operation room for old valve removal and replacement.Patient recovered and discharged.With speaking with the rn manager after the replacement surgery, she told me that when the heart valve was removed, they found the suture, operation room core knot, wasn't intact; it had broken.It is unclear what may have caused the break.The manager told me that this particular valve is new technology, anchored in with only three sutures; whereas in the past, most valves were placed with thirteen sutures.

• Brand Name: XENOGRAFT EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9086118
• MDR Text Key: 159127223
• Report Number: 9086118
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8300AB
• Device Catalogue Number: 8300AB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24090 DA
• Patient Weight: 129