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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problems Congestive Heart Failure (1783); High Blood Pressure/ Hypertension (1908); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A manufacturing related issue was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a 21mm valve was explanted after 23 days due to severe paravalvular leak and partial valve dehiscence.A 23mm valve was implanted in replacement.Per received records, the 21mm valve was partially dehisced at the nadir of the noncoronary sinus towards the commissure between the noncoronary cusp and the right coronary cusp.There appeared to be dense calcifications underneath the annulus that were right on the aortic mitral continuity that had likely prevented the valve from being seated well and likely some of the valve sutures were taken through this calcification and tore out once the heart was beating.This accounted for the paravalvular leak.The 21mm valve was explanted and replaced with a 23mm valve after debriding the calcifications further.The new valve was seated nicely.The patient tolerated the procedure well without complication and was transported to the icu in stable condition.

Manufacturer Narrative

F10.Device code: 3191 - dehiscence.

Event Description

It was reported that a 21mm valve was explanted after 23 days due to severe paravalvular leak and partial valve dehiscence.The patient had new onset chf and hypertension.A 23mm valve was implanted in replacement.The patient was discharged on pod #5.Per received records, the 21mm 11500a valve was partially dehisced at the nadir of the noncoronary sinus towards the commissure between the noncoronary cusp and the right coronary cusp.There appeared to be dense calcifications underneath the annulus that were right on the aortic mitral continuity that had likely prevented the valve from being seated well and likely some of the valve sutures were taken through this calcification and tore out once the heart was beating.This accounted for the paravalvular leak.The 21mm valve was explanted and replaced with a 23mm valve after debriding the calcifications further.The new valve was seated nicely.The patient tolerated the procedure well without complication and was transported to the icu in stable condition.The patient was discharged on pod #5.

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
• MDR Report Key: 9467796
• MDR Text Key: 172266527
• Report Number: 2015691-2019-04648
• 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: health professional,other,stu
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 07/23/2020
• Supplement Dates FDA Received: 01/07/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR