MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As reported, the issue occurred during implantation of the prosthetic valve.The patient's aorta was torn along both ends of the aortomy due to extensive manipulation of the valve.The device was successfully replaced with a smaller sized valve.There has been no allegation of device malfunction or deficiency.It has been determined that this event was most likely due to procedural related factors.The subject device is not available for evaluation as it was discarded by the customer.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a 27 mm pericardial aortic valve was explanted at implant due to the valve not being able to seat as a result of the patient's native anatomy.Also, it was reported that extensive manipulation of the 27 mm valve caused an aortic tear.It was noted that while the annulus measured at 27 mm the root was small and tight.An extension of the aortotomy was suggested, but the surgeon opposed this idea due to calcium on the aorta.The explanted valve was replaced with a 25 mm edwards pericardial aortic valve.Per the operative report, the patient had a fused, tricuspid, circular annulus.The aortic valve was excised after the annulus was carefully debrided.25 mm and 27 mm sizers were used.The annulus was sized at 27 mm, but the sizer had difficulty passing the sinotubular junction (stj) and did required manipulation.Three stitches were placed at the nadir of each sinus of valsalva.An attempt was made to place the 27 mm valve into the annulus.Despite extensive manipulation to the extent that the aorta was torn along both ends of the aortotomy, the valve could not be placed completely into the annulus.The valve was explanted and the annulus was re-sized with the 25 mm and 27 mm sizers once more.A 25 mm prosthetic valve was selected.The annulus was rimmed with pledgeted sutures placed in a horizontal mattress fashion.The explanted valve was replaced with a 25 mm aortic valve.The smaller sized valve did required some manipulation to cross the stj.Sutures were secured and good seating was confirmed.Transesophageal echocardiogram demonstrated a nicely seated aortic valve without evidence of paravalvular leak.Protamine was subsequently given.It was also noted that a cabg x1 was also performed.The patient was stable at the end of the procedure.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7465497
• MDR Text Key: 106654991
• Report Number: 2015691-2018-01544
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: 8300AB27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR