MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Material Perforation (2205); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Edwards received notification that a 11500a21 valve was explanted from the aortc position after approximately one (1) year and twenty two (22) days due to the detachment of the valve stitches leading to severe insufficiency (4+/4+) and moderate stenosis (gmax 50mmhg, gmed 29 mmhg).The patient presented with chest pain and shortness of breath before the explant procedure.As reported, during the post-explantation check, it was also noticed the presence of a small hole on a leaflet.According to the surgeon, the hole was created during the follow-up coronary angiography visit with the metal guide wire used to perform the angiography.Automated fasteners were not used.Endocarditis was ruled out.The valve was replaced with a 11500a23 valve.The patient was noted to be well and recovering.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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.

Manufacturer Narrative

H3: product evaluation: the device was returned for evaluation.Customer report of hole on leaflet was confirmed due to observed suture tail abrasions.Reports of detachment of the valve stitches, insufficiency, and stenosis were unable to be confirmed through visual observations.The x-ray demonstrated the wire form and cocr band remained intact; the vfit cocr alloy band was not expanded.As received, perforations were noticed on leaflets 1 and 2.The perforations were beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.Suture holes were observed around the sewing ring next to the three black stitch markings.Minimal host tissue overgrowth was observed on the outflow stent circumference and encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 1 on the outflow aspect.No other visible inconsistencies noted on the sewing ring.

Event Description

Edwards received notification that a 11500a21 valve was explanted from the aortc position after approximately one (1) year and twenty two (22) days due to the detachment of the valve stitches leading to severe insufficiency (4+/4+) and moderate stenosis (gmax 50mmhg, gmed 29 mmhg).The patient presented with chest pain and shortness of breath before the explant procedure.As reported, during the post-explantation check, it was also noticed the presence of a small hole on a leaflet.According to the surgeon, the hole was created during the follow-up coronary angiography visit with the metal guide wire used to perform the angiography.Automated fasteners were not used.Endocarditis was ruled out.Per product evaluation findings, the reported hole was characteristic of suture tail abrasion of which several were observed.The valve was replaced with a 11500a23 valve.The patient was noted to be well and recovering.

Manufacturer Narrative

The customer's complaint of dehiscence was unable to be confirmed, however, the reported leaflet damaged was confirmed through evidence of suture tail abrasion found during product evaluation.A dhr review was unable to be performed as no lot/serial number for the device was provided.An echocardiogram report was provided, however, there was no mention of the reported dehiscence or leaflet damage.Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device 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.Valve dehiscence is not a malfunction of the device.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.It was also reported that the presence of a small hole on a leaflet was noticed post-explantation of the valve.As stated in the instructions for use (ifu), once the sutures are completely tied, it is important to cut the sutures close to the knots to ensure that exposed suture tails will not come into contact with the leaflet tissue of the valve.Based on the product evaluation and available information, the report of "hole on leaflet" was confirmed and was likely caused by suture tail abrasions due to use error.An edwards defect has not been confirmed.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17143088
• MDR Text Key: 317529921
• Report Number: 2015691-2023-13928
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male