MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS-DUROMEDICS BILEAFLET PROSTHESES; HEART-VALVE, MECHANICAL

Model Number 3160

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Bone Fracture(s) (1870); Pulmonary Edema (2020); Regurgitation (2259); Cardiogenic Shock (2262)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Leaflet escape represents an entire or portion of mechanical leaflet separating/ breaking from the frame and embolizing distally.The embolization of the leaflet can cause obstruction in critical blood vessels resulting in tissue damage.In addition, the absence of leaflet in the heart valve will cause severe aortic regurgitation.The device was not returned for evaluation at this time.Follow up for the device is in progress.The root cause of the event remains indeterminable at this time.If new information is received a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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.

Event Description

Through review of medical article "spontaneous leaflet fracture resulting in embolization from mechanical valve prostheses" authors gijs g.J.Van steenbergen et al, the following event was identified as pertaining to an edwards mechanical valve: a 27-mm ed bileaflet mechanical prosthesis duromedix model 3160 was explanted after an implant duration of 31 years due severe regurgitation secondary to a leaftet fracture.As reported, this (b)(6) year-old male presented to a local hospital with cardiogenic shock.His previous medical history included endocarditis 31 years ago for which he underwent antibiotic treatment and aortic valve replacement with this 27-mm ed bileaflet mechanical prosthesis.A computed tomography (ct) of thorax and abdomen showed a saccular aneurysm of the ascending aorta measuring 83 × 47mm (at the level of the previous aortotomy), and changes consistent with pulmonary edema.Coronary angiography (cag) demonstrated no coronary abnormalities; however, it confirmed severe aortic regurgitation and the absence of one leaflet of the mechanic aortic valve prosthesis.Subsequent echocardiography confirmed a severe aortic regurgitation with preserved left ventricular function.The patient was intubated and transferred for emergent operative therapy.The valve prosthesis and diseased ascending aorta and aortic root were excised and replaced with a perimount magna ease biological aortic valve and a vascular graft, with reimplantation of the coronary ostia.The patient made an uneventful recovery and remained asymptomatic one year following surgery.

Manufacturer Narrative

Additional manufacturer narrative: the device was returned for evaluation and the report of regurgitation and leaflet fracture were confirmed from observed detached fragmented leaflet.As received, one of the mechanical valve leaflets was detached from the valve.Detached leaflet was fractured and leaflet fragment was not returned with valve.Remaining intact leaflet opened and closed without difficulty.Host tissue on the sewing ring was moderate on both inflow and outflow aspects.Sewing ring had multiple cuts around the valve.Multiple sutures remained attached to the sewing ring.Valve will be sent to r&d for observational evaluation.A supplemental report will be submitted upon completion.

Manufacturer Narrative

H10.Additional manufacturer narrative: the device was evaluated by r&d.A fracture analysis was performed to determine the cause of the leaflet escape.The leaflet escape was due to a fracture that initiated at a pit, located on the inflow surface near the major radius, approximately one third of the way from the leaflet center line to pivot 2.The pit morphology is consistent with cavitation/erosion damage in pyrolytic carbon.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

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

• Brand Name: EDWARDS-DUROMEDICS BILEAFLET PROSTHESES
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8947911
• MDR Text Key: 160903777
• Report Number: 2015691-2019-03243
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P850006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR