MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS; TISSUE, HEART-VALVE

Model Number 11500A

Device Problems Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.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.There can be several root causes of leaflet immobility or leaflet restriction.There may be cases where the leaflet or leaflets are not functioning as intended leading to regurgitation.A manufacturing related issue was not identified.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that echo showed restricted leaflet motion after 9 months from implantation of a 21mm valve.Reportedly, the leaflets appear to be moving normally but slightly restricted in their motion.As reported, this patient preferred to have a bioprosthetic valve because of an active lifestyle (runner, avoid oac).The surgeon tried to convince him for having a mechanical valve but finally agreed and implanted the inspiris valve.Post-op echos at 1 month showed a normal valve function, the patient was doing well.A tee at about 8 weeks post surgery showed an eoa of 0.8 and gradient above 60, all leaflets seemed to be moving.On control echo at 9 months restricted leaflet motion was observed.Recent echo showed normal leaflet thickening, no regurgitation and no evidence of degeneration.Valve thrombosis was excluded.However, the internal diameter appeared to be very small.As per the surgeon, the stent posts look like they have been pushed or closed in.As per the surgeon, the cause for this is unknown.It was suggested that the higher gradients and reduced eoa are due to constrained valve stents and reduced internal diameter leading to patient prosthesis mismatch.No further action was reported.The patient is considering a valve in valve procedure but the surgeon feels a surgical intervention would be better.Patient was noted to be asymptomatic.

Event Description

Edwards received notification that echo showed restricted leaflet motion after 9 months from implantation of a 21mm valve.Reportedly, the leaflets appear to be moving normally but slightly restricted in their motion.As reported, this patient preferred to have a bioprosthetic valve because of an active lifestyle (runner, avoid oac).The surgeon tried to convince him for having a mechanical valve but finally agreed and implanted the bioprosthetic valve.Post-op echose at 1 month showed a normal valve function, the patient was doing well.A tee at about 8 weeks post surgery showed an eoa of 0.8 and gradient above 60, all leaflets seemed to be moving.On control echo at 9 months restricted leaflet motion was observed.Recent echo showed normal leaflet thickening, no regurgitation and no evidence of degeneration.Valve thrombosis was excluded.However, the internal diameter appeared to be very small.As per the surgeon, the stent posts look like they have been pushed or closed in.As per the surgeon, the cause for this is unknown.It was suggested that the higher gradients and reduced eoa are due to constrained valve stents and reduced internal diameter leading to patient prosthesis mismatch.No further action was reported.The patient is considering a valve in valve procedure but the surgeon feels a surgical intervention would be better.Patient was noted to be asymptomatic.

Manufacturer Narrative

H3.Device evaluation: customer reports of patient prosthesis mismatch and perivalvular leak could not be confirmed through visual observations.Report of stent distortion was not confirmed.The x-ray demonstrated the wireform and band remained intact; the vfit alloy band was not expanded.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm on leaflet 2 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 4mm on leaflet 1 at the outflow aspect.Host tissue on the stent circumference was moderate at the outflow aspect.Approximately 80% of the sewing ring was cut off around the valve and exposed the wireform on the inflow aspect.Cut off sewing ring fragment was not returned with valve.A suture remained attached to the host tissue on the sewing ring around leaflet 2.

Manufacturer Narrative

Edwards received notification that echo showed high gradients likely due to constrained valve stents and reduced internal diameter leading to patient prosthesis mismatch in a patient with a 21mm valve, however cause was not clear.¿ the valve was returned for evaluation.Product evaluation confirmed host tissue overgrowth on the returned device.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.¿ host fibrous (pannus) tissue growth is not a malfunction of the device.The pannus overgrowth most likely occurred due to patient factors.

Event Description

Edwards received notification that echo showed high gradients likely due to constrained valve stents and reduced internal diameter leading to patient prosthesis mismatch in a patient with a 21mm valve; however the cause was not clear.As reported, this patient preferred to have a bioprosthetic valve because of an active lifestyle (runner, avoid oac).The surgeon tried to convince him for having a mechanical valve but finally agreed and implanted the valve.Post-op echos at 1 month showed a normal valve function, the patient was doing well.A tee at about 8 weeks post surgery showed an eoa of 0.8 and gradient above 60, all leaflets seemed to be moving.Recent echo showed normal leaflet thickening, no regurgitation and no evidence of degeneration.Valve thrombosis was excluded.However, the internal diameter appeared to be very small.As per the surgeon, the stent posts look like they have been pushed or closed in.Gradients: peak 68 mmhg and mean 38 mmhg.Dvi 0.25.V.Max 4.1 m/s.Eoa 0.9-1 cm^2.As per the surgeon, the cause for this is unknown.It was suggested that the higher gradients and reduced eoa are due to constrained valve stents and reduced internal diameter leading to patient prosthesis mismatch.New echo showed that the valve was seated high above the annulus (potentially too high) and the valve function was normal.The leaflets are unrestricted and had normal motion.The problem was a significant and large paravalvular leak around the base of the valve.Cause is not clear.It is not known if the valve was distorted or put out of shape during the implant.As per surgeon opinion, the patient required a root enlargement and potentially a larger valve implanted.Surgeon thought the echo showed normal valve function.Patient was noted to have shortness of breath, same as before the operation.The device was explanted after an implant duration of approximately 1 year and 6 months and returned for evaluation.A 23mm valve was implanted as a replacement, plus ascending aorta.Outcome was noted to be excellent.As per explant surgeon's opinion, the original valve was undersized and thus it became rigid.As per product evaluation, host tissue was found on this valve.

Manufacturer Narrative

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

• Brand Name: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9354402
• MDR Text Key: 194924524
• Report Number: 2015691-2019-04309
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/01/2019

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 Expiration Date: 07/17/2019
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 08/25/2020; 09/16/2020; 07/23/2020
• Supplement Dates FDA Received: 12/11/2019; 09/01/2020; 09/30/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 76