FDA Adverse Event Injury Summary report: N

PERCEVAL SUTURELESS AORTIC HEART VALVE

MDR report key: 10054570 · Received May 13, 2020

Report

Report Number
1718850-2020-01079
Event Type
Injury
Date Received
May 13, 2020
Report Date
May 13, 2020
Manufacturer
LIVANOVA CANADA CORP.
Product Code
LWR
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

FROM PUBLICATION PAPER. CARDIOL RES. 2020;11(2):113-117. EARLY STRUCTURAL DETERIORATION OF A SUTURELESS BIOPROSTHETIC AORTIC VALVE MICHAEL CINELLIA, D, LEONARD SCHWARTZA, JONATHAN SPAGNOLAB, IOSIF GULKAROVC, FRANK ROSELLC, ADAM LACKEYC, MOHAMMED IMAMC, CHARLES SCHWARTZB. ABSTRACT: SUTURELESS BIOPROSTHETIC VALVES SUCH AS THE SORIN PERCEVAL S VALVE (SPV) HAVE BEEN USED IN PATIENTS WITH AORTIC STENOSIS THAT REQUIRE SURGICAL AORTIC VALVE REPLACEMENT (SAVR). THESE PROSTHESES HAVE BEEN MARKETED ON THE BASIS OF THEIR RAPID IMPLANTATION TECHNIQUES WITH AVOIDANCE OF SUTURES AND REDUCED AORTIC CROSS-CLAMP TIMES. WE REPORT A CASE OF AN EARLY FAILURE OF A SPV NEARLY 4 YEARS AFTER IMPLANTATION IN A (B)(6)-YEAR-OLD WOMAN WHO WAS LOW-RISK. WHILE THE PATIENT¿S SYMPTOMS INITIALLY IMPROVED WITH SAVR WITH A SUTURELESS BIOPROSTHETIC VALVE, THEY PROGRESSIVELY WORSENED AS THE VALVE DEGRADED, AND THE LEAFLETS BECAME INCREASINGLY CALCIFIED AND STENOTIC ULTIMATELY, REQUIRING REOPERATIVE SAVR WITH A ST. JUDE MECHANICAL VALVE. THIS CASE RAISES THE ISSUE OF THE LACK OF MUCH-NEEDED DATA DESCRIBING THE LONG-TERM DURABILITY AND HEMODYNAMIC PERFORMANCE OF THESE VALVES, PARTICULARLY IN A LOW-RISK PATIENT WITH EXCELLENT FUNCTIONAL STATUS. WE HOPE TO SHED FURTHER INSIGHT INTO THE LACK OF LONG-TERM STUDIES ON PATIENTS WITH SPV TO ASSESS THEIR LONGEVITY AND LONG-TERM EFFECTIVENESS, AS WELL AS ELUCIDATION OF POSSIBLE PREVENTION AND MONITORING OF THESE POTENTIAL COMPLICATIONS. THE USE OF NEWER GENERATION PROSTHESES, ALTHOUGH ATTRACTIVE FOR THEIR EASE OF IMPLANTATION, POTENTIALLY CARRIES HIGHER LONG-TERM RISK DUE TO SHORTER DURABILITY LEADING TO REINTERVENTION TO ADDRESS VALVE DETERIORATION. THIS IS ESPECIALLY TRUE IN LOW-RISK PATIENTS WHO ARE YOUNG AND ACTIVE. CARDIOLOGY AND CARDIOTHORACIC SURGERY SOCIETIES NEED TO DEVELOP A UNIVERSAL REGISTRY WITH FOLLOW-UP OF ALL VALVES IN ORDER TO TRACK AND STUDY THE DURABILITY OF THESE VALVES, AND TO EVALUATE FOR INCIDENCE OF KNOWN AND POTENTIAL COMPLICATIONS. SUMMARY: A (B)(6)-YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF SAVR 4 YEARS PRIOR WITH SPV DUE TO CALCIFIC AS, HISTORY OF MYOCARDIAL INFARCTION STATUS POST PERCUTANEOUS CORONARY INTERVENTION TO THE RIGHT CORONARY ARTERY, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, OBSTRUCTIVE SLEEP APNEA, CROHN¿S DISEASE, THALASSEMIA TRAIT, AND GASTROESOPHAGEAL REFLUX PRESENTED WITH PROGRESSIVE EXERTIONAL DYSPNEA, PAROXYSMAL NOCTURNAL DYSPNEA, AND CHEST DISCOMFORT FOR THE PAST 6 MONTHS. HER MEDICATIONS INCLUDED AMLODIPINE, LOSARTAN, FUROSEMIDE, ASPIRIN, CLOPIDOGREL, METOPROLOL SUCCINATE, ATORVASTATIN, PANTOPRAZOLE, AND BUDESONIDE/FORMOTEROL. HER CALCIUM WAS 8.9 MG/DL AND PHOSPHORUS WAS 3.6 MG/DL. HER CREATININE WAS 0.8 MG/DL WITH A GLOMERULAR FILTRATION RATE OF 81 ML/MIN/1.73M2. B-TYPE NATRIURETIC PEPTIDE (BNP) WAS 6,960 PG/ML. HER HEMOGLOBIN WAS 11.7 G/DL AND HEMATOCRIT WAS 35.6%. PROTHROMBIN TIME (PT) WAS 11.6 S, ACTIVATED PARTIAL THROMBOPLASTIN TIME WAS 26.7S AND INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.07, WHICH WERE AROUND HER BASELINE. ALL OTHER ROUTINE LAB WORK INCLUDING CARDIAC ENZYMES WAS UNREMARKABLE. CHEST X-RAY SHOWED BILATERAL INTERSTITIAL OPACITIES. AN ELECTROCARDIOGRAM (ECG) SHOWED NORMAL SINUS RHYTHM. TRANSTHORACIC ECHOCARDIOGRAM REVEALED BIOPROSTHETIC AS WITH A PEAK AORTIC VELOCITY OF 4.83 M/S, A PEAK TRANSAORTIC GRADIENT OF 93.39 MM HG, A MEAN TRANSAORTIC GRADIENT OF 53.0 MM HG, AN AORTIC VALVE AREA OF 0.62 CM2, MILD TO MODERATE MITRAL VALVE REGURGITATION, LEFT VENTRICULAR EJECTION FRACTION OF 60%, AND SEVERE AORTIC ROOT CALCIFICATION. THE PATIENT WAS EVALUATED IN VALVE CLINIC, AND WAS INITIALLY CONSIDERED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). SHE UNDERWENT CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) AND TAVR CTA TO EVALUATE FOR ACCESS. THE BIOPROSTHETIC AORTIC VALVE LEAFLETS WERE NOTED TO BE THICKENED AND CALCIFIED CONSISTENT WITH SEVERE BIOPROSTHETIC AORTIC VALVE FAILURE. VALVE-IN-VALVE (VIV)-TAVR WAS CONSIDERED BY THE STRUCTURAL HEART TEAM, BUT GIVEN THE PATIENT¿S YOUNG AGE, EXCELLENT FUNCTIONAL STATUS, AND POTENTIAL FOR REQUIRING ANOTHER AORTIC VALVE REPAIR (AVR) IN HER LIFETIME, IT WAS DECIDED THAT SAVR WITH A MECHANICAL VALVE WAS A BETTER OPTION. A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED NO EVIDENCE OF INFECTIVE ENDOCARDITIS BUT DEMONSTRATED SIGNIFICANT CALCIFIED PANNUS, WHICH RAISED CONCERN FOR RISK OF EMBOLIZATION WITH TAVR. THE PATIENT¿S SOCIETY OF THORACIC SURGEONS (STS) SCORE WAS CALCULATED TO BE 4%. CARDIAC CATHETERIZATION SHOWED NO SIGNIFICANT CORONARY ARTERY DISEASE. THE PATIENT UNDERWENT A SUCCESSFUL REOPERATIVE SAVR WITH A 23-MM ST. JUDE MECHANICAL AORTIC VALVE VIA STERNOTOMY. INTRAOPERATIVELY, THE SPV WAS EXPLANTED AND SEVERELY CALCIFIED, AND STIFFENED LEAFLETS WERE NOTED, CONSISTENT WITH THE ECHOCARDIOGRAM. THE PATIENT WAS STARTED ON ANTICOAGULATION WITH COUMADIN FOR THE ST. JUDE MECHANICAL VALVE. SHE FELT MARKED RELIEF IN HER SYMPTOMS TO THE EXTENT OF NO LONGER REQUIRING CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY FOR HER OBSTRUCTIVE SLEEP APNEA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
518282 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. TDB

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention