MAUDE Adverse Event Report: LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number CNA21

Device Problems Calcified (1077); Degraded (1153); Material Too Rigid or Stiff (1544)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Dyspnea (1816); Pulmonary Edema (2020); Renal Failure (2041)

Event Date 07/04/2019

Event Type  Injury  

Event Description

On (b)(6) 2016, a crown prt was implanted in a patient.The echo performed 3 months after the intervention, the prosthesis appeared to be functioning well, with a slight intra-prosthetic aortic insufficiency the crown was explanted on (b)(6) 2019 due to structural valve deterioration.The valve appeared rigid without fusion of veils, with significant stenosis (transvalvular gradient 77/36) and with severe aortic insufficiency.A perceval pvs21 was ultimately implanted in the patient.It is reported that one year after the crown implantation, coinciding with a hernia intervention, the patient started experiencing progressive dyspnea until the patient was admitted to hospital.Upon admission, the patient presented with acute pulmonary edema, treated with diuretic treatment.Renal insufficiency, anuria, hyper k+.The patient was transferred to the icu and treated with rrt (renal replacement therapy).The patient also required infusion of nad due to the low tolerance of rrt.

Manufacturer Narrative

The device was returned to the manufacturer and it was received on 13 sep 2019.The returned valve was received in dry conditions but still wet.Slight traces of pannus have been observed on the pericardium and the delrin stent was partially uncovered because the covering fabric was damaged.The leaflets appeared stiffened, with traces of calcification and two of them presented a tear at the cusp junction.In general, the valve appeared geometrically deformed.

Event Description

On (b)(6) 2016, a patient received a crown cna21 in aortic position.Three months after the surgery ((b)(6) 2016), the echo showed a good functionality of the prosthesis, with a slight intra-prosthetic aortic insufficiency.The patient is asymptomatic during the first year after the surgery.However, in (b)(6) 2017, coinciding with a hernia intervention (subxiphoid eventration with implantation of a mesh), the patient started experiencing moderate-small effort dyspnea.An aortic murmur was detected but no control echocardiography is available until (b)(6) 2019, when the patient was urgently admitted to the hospital due to acute pulmonary edema.Significant prosthetic dysfunction is observed at this time.After treating the acute pulmonary edema with non-invasive ventilation and depletive treatment, re-do aortic surgery was planned.Upon admission to the hospital, renal insufficiency was also detected and treated with renal replacement therapy before the re-do aortic surgery.On (b)(6) 2019, the cna21 was explanted.The valve appeared rigid without fusion of veils, with significant stenosis (transvalvular gradient 77/36) and with severe aortic insufficiency.A perceval pvs21 was ultimately implanted in the patient.A good postoperative course is reported after the re-do surgery.The pericardial fluid and the explanted valve were tested to rule out endocarditis and the result was negative.It was also confirmed that the patient did not have chronic renal failure, so this has not been able to contribute to the early degeneration of the valve.

Manufacturer Narrative

A minor correction in the results of the investigation is presented hereunder.The results of the document review and the conclusion remains unchanged.The visual and histological analysis confirmed the presence of a tear at the cusp junction in two leaflets.Deformation of the prosthesis was confirmed by the visual and dimensional analysis.Leaflets calcification was detected with visual, x-ray and histological analyses.The morpho-histological analysis showed the presence of calcified thrombus depositions on one leaflet.The pericardium of all leaflets was thicker than normal due to calcification.Pericardial delaminations were detected in all the leaflets.The collagen bundles were disrupted, deliberated and homogenated in two leaflets.Thin fibrous pannus depositions were visible on the mesothelial surface of one leaflet.Bacteria were not detected with the gram stain.The calcification detected in the leaflets caused their stiffening and led to progressive valve stenosis.Aortic insufficiency likely resulted from leaflets tears and inadequate leaflet coaptation caused by their calcification.There was no evidence of endocarditis in the returned valve, in agreement with the information provided by the field.

Manufacturer Narrative

Fields updated: b4, f7, f10.Leaflets calcification was detected with visual, x-ray and histological analyses.The histological analysis showed that the collagen bundles were disrupted, defibrated and homogenated in two leaflets.Thin fibrous pannus depositions were visible on the mesothelial surface of one leaflet.Bacteria were not detected with the gram stain.The leaflets calcification caused their stiffening and led to progressive valve stenosis.Aortic insufficiency likely resulted from leaflets tears and inadequate leaflet coaptation caused by their calcification.There was no evidence of endocarditis in the returned valve.Furthermore, the manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.Based on the available information, it is not possible to draw a definite conclusion on the root cause of the reported structural valve deterioration.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical conditions and risk factors (hypertension and dyslipidemia) may have contributed to the structural valve deterioration observed in this crown valve.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8848739
• MDR Text Key: 152907834
• Report Number: 1718850-2019-01056
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2019,10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90