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

Model Number 11060A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/16/2022

Event Type  Injury  

Manufacturer Narrative

Additional narratives: dehiscence of aortic valved conduit may occur early or late.When it occurs in the early postoperative period, it is typically a result of an inadequate prosthetic device implantation in combination with friable patient tissue.Late dehiscence can occur as a result progression of patients disease or infection.If intervention to treat the dehiscence was performed after the initial implant surgery, the event is reportable.In this case only the graft part of the konect was implanted (off- label use) and there was bleeding post operatively.There was no allegation of a device malfunction, however, the patient required intervention after the initial procedure to place a single pledged suture that was placed along the proximal aortic suture line which improved the situation.The device was not returned for evaluation, as there was no allegation of valve portion.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was learned through the implant registry that the graft part only of a 23mm 11060a aortic valved conduit was implanted.Post operatively the patient underwent emergency mediastinal exploration for bleeding.Per medical records this case involved a 43-year-old male patient with a history of marijuana use.The patient was admitted with a type a focal in the ascending aorta with aneurysmal proximal ascending aorta with evidence of intramural versus subepicardial hematoma and moderate to severe native aortic insufficiency.The patient had altered loc, drug screen was positive for cocaine.The patient underwent emergency surgery.The patient underwent avr and replacement of the ascending aorta the aortic valve was replaced with a 23mm 11500a aortic valve.It is noted both coronary ostia were visualized and were unobstructed.The 26mm dacron graft was prepared and tailored appropriately for the distal anastomosis.The proximal portion of the graft was tailored appropriately, and the proximal anastomosis fashioned with continuous 3-0 prolene.It is noted along the root there was a focal defect in the aorta just distal to the stj above the commissure of the left and right coronary cusps.The ascending aorta was aneurysmal proximally, but the aneurysm resolved at the mid ascending aorta, the arch was not dissected.Following completion of the repair the av valve was well seated, functioning appropriately with no pvl.The patient was treated with multiple blood products for post op coagulopathy and thrombocytopenia.The patient was transferred to cicu in critical condition.The patient underwent emergency mediastinal re exploration for bleeding on pod #0.A single pledgeted suture was passed along the proximal aortic suture line which seemed to improve the situation.The patient was returned to cicu.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 root cause of the dehiscence was use error, as the 11060a valve was cut off and only the graft was used off label.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.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 15966079
• MDR Text Key: 305342683
• Report Number: 2015691-2022-09953
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)230914
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: 11060A
• Device Catalogue Number: 11060A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: 43 YR
• Patient Sex: Male