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

Model Number 8300

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/23/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Aortic tears, or a tear of the aortic wall, may occur as a complication of cardiac surgery involving a diseased aortic root.Additional causes of aortic tears or a tear of the aortic wall may be related to the use or misuse of the edwards intuity valve.These aortic injuries are life threatening conditions that require urgent intervention with suture repair, pericardial patch repair or aortic root replacement.A manufacturing related issue was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors such as fragile tissue contributed to the event.As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based on the determined control limits, appropriate investigation will be performed.No corrective or preventative actions are required at this time.

Event Description

Edwards received notification that a patient was submitted to avr with a 23 mm device and 1 cabg.After implant, tee was performed and valve was placed properly, no leak was found, mean gradient of 8 mmhg.As reported, the valve was implanted in full sternotomy.After closing aortotomy and weaning from cpb it was noticed continuous bleeding observed at the level of the aortic posterior wall, near the aortotomy sutures, above the stj.The surgeon tried to control the bleeding with bio-glue but it did not work.The patient was put back on cpb and aortotomy was re-opened.The glue and some clots were removed and a pericardium patch was placed to rebuilt the torn aortic wall.The patient started to present bradycardia and left the or with a temporary pacemaker.Patient was taken to icu and was stable until he started to present progressive hypotension needing high doses of vasoactive drugs.The patient was reoperated again the day after.When the surgeon reached the heart it was found that the patient was very hypovolemic and soon he presented a cr arrest that took about 40 minutes.Instead of a specific point of bleeding, the surgeon found a diffuse bleeding probably due to a new coagulopathy.Patient left the or with high doses of noradrenaline and dobutamine (20 mcg/kg/min).At icu he was put under mechanical ventilation, sedated, with no urinary debit.A dialysis access was placed.Patient died on pod # 2, couldn¿t stand dialysis and kept a refractory metabolic acidosis.As per surgeon's opinion, the causes of the event might be aorta tissue fragility and unknown coagulopathy that the patient could have and medical team didn¿t know.

• 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; lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7118026
• MDR Text Key: 94864713
• Report Number: 2015691-2017-04284
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2018
• Device Model Number: 8300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Date Device Manufactured: 05/26/2016
• 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): Death; Required Intervention
• Patient Age: 62 YR