MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 8300AB19

Device Problems Incomplete Coaptation (2507); Material Twisted/Bent (2981)

Patient Problems Aortic Valve Stenosis (1717); Death (1802); Pulmonary Edema (2020); Regurgitation (2259); No Code Available (3191)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

In this case, it was reported that the valve was explanted on pod #0 due to suture loop, mild/moderate regurgitation, and leaflet restricted motion.The surgeon noted that two of the cor-knotted commissure sutures (r/n, l/n) looped around the valve posts.The surgeon also commented that the suture loops may have restricted the leaflet motion.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that procedural factors contributed to the event.If new information is received, a supplemental report will be submitted.The device was not available for return as it was discarded.The device history record (dhr) review is pending, a supplemental report will be submitted upon completion.

Event Description

It was reported that a 19mm pericardial aortic valve was explanted on pod #0 due to suture loop, mild/moderate regurgitation, and leaflet restricted motion.A pericardial aortic valve was implanted in replacement.On pod #1 the sales rep was notified that patient expired; the exact date of death was unknown.As reported, a (b)(6) year-old female patient presented as/ai; the case was an avr with a right anterior thoracotomy approach.A hockey stick aortotomy was performed.Excision of valve leaflets and debridement was uneventful.The surgeon sized annulus per the ifu and used 19, 21, 23 sizers several times, both the barrel and replica ends as suggested in the ifu.A 19mm valve was selected, prepped, and implanted.The surgeon used 3 mattress sutures, and 3 commissure sutures.Placing of the sutures took an unusually long time.The surgeon seated the valve and expanded the frame per protocol.The surgeon used the cor-knot device to the tie down the sutures.Upon examining the valve, the surgeon noted that the non-coronary cusp "seemed tight" and stated one of the leaflets seemed "different".The surgeon stated that after the irrigation the leaflets looked ok, the valve looked fine, and he was ready to close the aorta.The initial transesophageal echocardiogram (tee) images looked fine.Anesthesia commented that they saw no pvls, or ai.The clamp time was 190 minutes.The team started warming patient, and initiated weaning patient from bypass.Then the blood pressure dropped.Perfusion and anesthesia were not able to stabilize the mean arterial pressure (map).Attempts to get patient off bypass failed.The tee later revealed restricted leaflet motion and mild/moderate ai across the valve.High pulmonary artery pressures and signs of pulmonary edema were noted.The decision was made to reopen the chest.Conversion to a full sternotomy was decided and completed.The aorta was re-clamped and the heart was arrested.Upon opening of the aorta, surgeon noted that two of the cor-knotted commissure sutures (r/n, l/n) looped around the valve posts.The surgeon commented that the suture loops may have restricted the leaflet motion (nc).The sutures were cut and removed.The third commissure suture was left in place along with the 3 mattress sutures.Surgeon felt that the valve now looked fine, and it did not need to be replaced and stated that he could see no damage to the leaflets and the leaflets were intact.The aorta was closed and the patient was rewarmed.Once the clamp was removed, the patient was paced.Once again, the team had a hard time keeping the map within range.Pa pressures were high.Signs of severe pulmonary edema presented.Initiations to remove patient from bypass failed.The tee revealed mild/moderate ai and a map of 30-40.The patient was stable, and on bypass by the time the sales rep left the or.The next day rep was notified that the 19mm pericardial aortic valve was explanted, and replaced with another pericardial aortic valve.No additional details were provided.

Event Description

It was reported that an 19mm was explanted on pod #0 due to suture loop, mild/moderate regurgitation, and leaflet restricted motion.A magna ease was implanted.On pod #1 rep was notified that patient expired; exact date of death was unknown.As reported, a 53 yrs old female patient presented as/ai; the case was an avr with rat approach; groin cannulation was performed and right femoral vein and left femoral artery were cannulated.Bypass initiation were uneventful.Aorta was clamped, and heart was arrested.Hockey stick aortotomy was performed.Excision of valve leaflets and debridement were uneventful.Surgeon sized annulus per ifu and used 19, 21, 23 sizers several times, both barrel and replica end as suggested in ifu.A 19mm valve was selected, prepped and implanted.Surgeon used 3 mattress sutures, and 3 commissure sutures.Placing the sutures took an unusually long time.Surgeon seated the valve and expanded the frame per protocol.Surgeon used the cor-knot device to the tie down the sutures.Upon examining valve, surgeon noted that the ncc "seemed tight" and stated one of the leaflets seemed "different".Surgeon irrigated per rep¿s suggestion.Surgeon stated that after the irrigation the leaflets looked ok, the valve looked fine, he was ready to close the aorta.Once the aorta was closed, the cross clamp was removed, and the heart was filled per protocol.The initial tee images looked fine, anesthesia commented that they saw no pvls, or ai.Clamp time was 190 minutes.The team started warming patient, and initiated weaning patient from bypass.Then the blood pressure was dropped.Perfusion and anesthesia were not able to stabilize map.Attempts to get patient off bypass failed.Tee later revealed restricted leaflet motion and mild/moderate ai across the valve.High pa pressures and signs of pulmonary edema were noted.Decision was made to reopen the chest.Conversion to a full sternotomy was decided and completed.Aorta was re-clamped.Heart was arrested.Del nido crystalloid cardioplegia solution was used and re-dosed several times during the procedure.Upon opening of aorta, surgeon noted that two of the cor-knotted commissure sutures (r/n, l/n) looped around the valve posts.Surgeon commented that the suture loops may have restricted the leaflet motion (nc).The sutures were cut and removed.The third commissure suture was left in place along with the 3 mattress sutures.Surgeon felt that the valve now looked fine, and it did not need to be replaced and stated that he could see no damage to the leaflets and the leaflets were intact.Aorta was closed per protocol.Patient was rewarmed.Once clamp was removed, patient was paced.Once again, the team had a hard time keeping map within range.Pa pressures were high.Signs of severe pulmonary edema presented.Initiations to remove patient from bypass failed.Tee revealed mild/moderate ai.Map of 30-40.The patient was stable, and on bypass by the time rep left the or.The next day rep was notified that the valve was explanted, and replaced with another pericardial aortic valve.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Updated b5.Per additional information received through follow up.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7798322
• MDR Text Key: 117694068
• Report Number: 2015691-2018-03443
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2018
• Device Model Number: 8300AB19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR