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

Model Number 11500A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was learned through implant patient registry, investigation and medical records that a 23mm 11500a aortic valve in aortic position was explanted at implant due to a linear tear just above the right coronary ostia wrapped towards the coronary sinus.The patient underwent replacement with a 21mm 11060a avc.The patient was discharged on (b)(6).Per the customer, there was no allegation of device malfunction.Per medical records: a unicuspid aortic valve with a raphe (underdeveloped right and non coronary leaflets turning into a malformed commissure between the leaflets) was found at surgery with severe calcification.An anomalous rca originating from low on the non coronary cusp was also found.The aortic and annular tissue was found to be fragile.The rca button was diminutive, very fragile and could not be mobilized extensively given its anomalous course.The native aortic valve was excised entirely back to the aortic annulus and the annulus further debrided to remove residual calcium.The initial implant of the 23mm 11500a valve was performed via hemi-sternotomy.The valve appeared well seated and the coronary ostia were patient, there was a linear tear just above the right coronary ostia that was partial thickness and wrapped towards the coronary sinus.The surgeon suspects this was from the traction injury from the tightly fitting aortic valve prosthesis and the relatively weak aortic root tissue.The patient was converted to full sternotomy, it is noted the conversion to full sternotomy and root replacement was inherent to the procedure.The 23mm aortic valve was explanted and the patient underwent a bentall aortic root and valve replacement with a 21mm konect avc, with lca and rca reimplantation, and ascending aortic replacement with a 26mm graft.The patient was rewarmed and after a period of reperfusion, rv function appeared poor and over concerns for the rca button patency it was elected to perform cabg x 1 to the rca.The aortic valve noted to be functioning normally.The patient was successfully weaned from cpb with iabp support.The patient was enroute to icu when he had sudden vfib arrest, he was resuscitated and the chest reopened in or, the rca graft unobstructed but kinked during chest closure, a concurrent tee showed near normal biventricular function.The rca vein graft position was slightly changed and the situation resolved.The patient was successfully weaned from cpb with iabp support.A permanent pacemaker was inserted on (b)(6) due to heart block.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.

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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H11: additional manufacturer narrative: updated section h6 (type of investigation, investigation findings, investigation conclusions).There was no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The root cause of this event was determined to be due to procedural and patient related factors - patient factors (including a unicuspid aortic valve with an anomalous rca originating from low on the non-coronary cusp, a very fragile rca button that could not be mobilized extensively given its anomalous course, and a relatively weak aortic root) and procedural factors (including a linear tear just above the right coronary ostia wrapped towards the coronary sinus and the rca graft kinked during chest closure).The subject device is not available for return as it was discarded.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18877538
• MDR Text Key: 337358177
• Report Number: 2015691-2024-01932
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)271018(11)231019
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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): Life Threatening; Other
• Patient Age: 55 YR
• Patient Sex: Male