ON-X AORTIC VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2018-00153
- Event Type
- Death
- Date Received
- October 3, 2018
- Report Date
- December 5, 2018
- Manufacturer
- ON-X LIFE TECHNOLOGIES
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MULTIPLE REQUESTS TO THE CONTACT AUTHOR FOR ADDITIONAL CLARIFYING INFORMATION WERE MADE WITHOUT SUCCESS TO ACQUIRE THE FOLLOWING INFORMATION: DATES OF THE ON-X IMPLANTS, SERIAL NUMBERS OF THE ON-X VALVES, ANY ADVERSE EVENTS THAT OCCURRED FOR ON-X VALVE PATIENTS, AND THE CURRENT PATIENT STATUS OF THE ON-X VALVE RECIPIENTS. NO RESPONSE WAS RECEIVED. THE MANUFACTURING RECORDS FOR THE ON-X VALVES USED IN THE STUDY WERE NOT REVIEWED AS THE SERIAL NUMBERS WERE NOT PROVIDED. THE SYSTEM COULD NOT BE QUERIED FOR THE ON-X VALVES AS DATES OF IMPLANT WERE NOT PROVIDED. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE PUBLICATION BY LEE ET AL. AIMED TO EVALUATE THE LATE CLINICAL OUTCOMES OF NEW-GENERATION MECHANICAL VALVES FOR SEVERE AORTIC STENOSIS (AS) COMPARED WITH OLD MECHANICAL VALVES. REVIEW OF DATA WAS PERFORMED FROM 254 PATIENTS WITH SEVERE AS, WHO UNDERWENT PRIMARY MECHANICAL AORTIC VALVE REPLACEMENT FROM 1995 TO 2013. PATIENTS WERE CLASSIFIED INTO TWO GROUPS: OLD-VALVE GROUP (N=65; 33 ATS STANDARD, 32 MEDTRONIC-HALL) AND NEW-VALVE GROUP (N=189: 113 ST. JUDE REGENT, 46 ON-X, 30 SORIN OVERLINE). MEDIAN PATIENT AGE WAS 58 YEARS (Q1-Q3: 52-61). WITH PROPENSITY SCORE MATCHING BASED ON DEMOGRAPHIC INFORMATION, 56 PATIENTS IN THE OLD VALVE GROUP WERE MATCHED WITH 177 PATIENTS IN THE NEW-VALVE GROUP. THE MEDIAN FOLLOW-UP DURATION WAS 91 MONTHS (Q1-Q3: 48-138). CARDIAC-RELATED MORTALITY AND HEMORRHAGIC EVENTS WERE SIGNIFICANTLY LOWER IN THE NEW-VALVE GROUP (P=0.047 AND P=0.032, RESPECTIVELY). THE MEDIAN INTERNATIONAL NORMALIZED RATIO (INR) AT FOLLOW-UP WAS SIGNIFICANTLY HIGHER IN THE OLD-VALVE GROUP [2.23, Q1-Q3: 2.14-2.35 (OLD-VALVE GROUP); Q1-Q3: 1.92-2.23 (NEW-VALVE GROUP), P<0.001]. THE INCIDENCE OF PROSTHESIS-PATIENT MISMATCH (PPM) WAS SIGNIFICANTLY HIGHER IN THE OLD-VALVE GROUP (P<0.001). MULTIVARIATE ANALYSIS OF THE TOTAL POPULATION REVEALED THAT PPM WAS A SIGNIFICANT RISK FACTOR FOR CARDIAC RELATED EVENTS [HAZARD RATIO (HR) =5.279, 95% CL, 1.886-14.561, P=0.002] AND SHOWED HIGHER TREND OF INCREASING MORTALITY (HR = 3.082, P=0.076). NEW MECHANICAL PROSTHESES SHOWED A BETTER HEMODYNAMIC PERFORMANCE AND LOWER INCIDENCE OF PPM. ANTICOAGULATION STRATEGY TO LOWER THE TARGET INR INPATIENTS WITH NEW MECHANICAL VALVES MAY IMPROVE LATE OUTCOMES BY REDUCING HEMORRHAGIC EVENTS. 46 PATIENTS RECEIVED ON-X VALVES. IT IS NOT CLEAR WHICH REPORTED EVENTS WERE EXPLICITLY ASSOCIATED WITH ON-X VALVES. ATTEMPTS AT ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS SO NO DETERMINATION CAN BE MADE REGARDING THE RELATION OF IN-HOSPITAL ADVERSE EVENTS TO THE ON-X VALVE. TWO PACEMAKER IMPLANTS IN THE NEW VALVE GROUP COMBINED. THE CAUSES OF DEATH INCLUDED CEREBRAL HEMORRHAGE IN THREE, CEREBRAL INFARCTION IN TWO, ALVEOLAR HEMORRHAGE IN ONE, HEART FAILURE IN ONE, ISCHEMIC CARDIOMYOPATHY IN ONE, SUDDEN DEATH IN ONE, CANCER IN 6, AGING IN ONE, AND UNKNOWN IN 10 PATIENTS. THERE WERE SIX REOPERATIONS. THE CAUSES OF REOPERATION WERE INFECTIVE ENDOCARDITIS IN THREE, PANNUS FORMATION IN TWO, AND MALFUNCTION OF MECHANICAL VALVE IN ONE PATIENT. NO DETERMINATION CAN BE MADE REGARDING THE RELATION OF THE ABOVE-MENTIONED ADVERSE EVENTS TO THE ON-X VALVE. BLEEDING EVENTS WERE SIGNIFICANTLY HIGHER IN THE OLD-VALVE GROUP [8.9% (OLD-VALVE GROUP) VS. 1.1% (NEW-VALVE GROUP), P=0.010]. NO DETERMINATION CAN BE MADE REGARDING THE RELATION OF THE ABOVE-MENTIONED ADVERSE EVENTS TO THE ON-X VALVE. THROMBOEMBOLIC EVENTS DID NOT DIFFER BETWEEN GROUPS [7.1% (OLD-VALVE GROUP) VS. 3.4% (NEW-VALVE GROUP), P=0.258]. NO OTHER INFORMATION WAS MADE AVAILABLE REGARDING PATIENT ANTICOAGULATION COMPLIANCE AND INR PRECEDING THE LATE EVENTS RECORDED. THROMBOEMBOLISM AND HEMORRHAGE ARE RECOGNIZED POTENTIAL COMPLICATIONS ASSOCIATED WITH PROSTHETIC MITRAL VALVE REPLACEMENT. OBJECTIVE PERFORMANCE CRITERIA REPORT AN HISTORICAL THROMBOEMBOLIC INCIDENCE OF 3.0% PER PATIENT-YEAR AND ALL HEMORRHAGE OF 3.5% PER PATIENT-YEAR FOR ALL RIGID PROSTHESIS VALVES [ISO 5840:2005]. DEFINITIVE ROOT CAUSES FOR THE REPORTED EVENTS CANNOT BE DETERMINED; HOWEVER, ADVERSE EVENT RATES OBSERVED ARE COMPARABLE TO THOSE IN LITERATURE. ULTIMATELY, THE AUTHORS STATE THAT VARIOUS STATISTICAL METHODS CONSISTENTLY INDICATED A LOWER CARDIAC-RELATED MORTALITY RATE (0.121< HR <0.171) AND ANTICOAGULATION-RELATED EVENTS (0.229< HR <0.566) IN THE NEW-VALVE GROUP THAN IN THE OLD-VALVE GROUP. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT¿S LABELING AND INSTRUCTIONS FOR USE.
ACCORDING TO THE PUBLICATION "LATE CLINICAL OUTCOMES AFTER MECHANICAL AORTIC VALVE REPLACEMENT FOR AORTIC STENOSIS (AS): OLD VERSUS NEW PROSTHESES" BY PYO WON PARK, HEEMOON LEE, KIICK SUNGA, ET. AL., A COMPARATIVE STUDY WAS CONDUCTED TO EVALUATE THE LATE CLINICAL OUTCOMES OF NEW-GENERATION MECHANICAL VALVES FOR SEVERE AORTIC STENOSIS COMPARED WITH OLD MECHANICAL VALVES. DATA WAS RETROSPECTIVELY STUDIED FROM 254 PATIENTS WITH AS WHO UNDERWENT PRIMARY MECHANICAL AORTIC VALVE REPLACEMENT FROM 1995 TO 2013. PATIENTS WERE PLACED INTO TWO GROUPS CLASSIFIED AS ¿OLD-VALVE GROUP¿ AND ¿NEW-VALVE GROUP.¿ THE OLD-VALVE GROUP CONSISTED OF 65 RECIPIENTS RECEIVING 33 ATS STANDARD VALVES AND 32 MEDTRONIC-HALL VALVES. THE NEW VALVE GROUP CONSISTED OF 189 RECIPIENTS RECEIVING 113 ST. JUDE REGENT VALVES, 46 ON-X VALVES, AND 30 SORIN OVERLINE VALVES. SUMMARY OF THE OUTCOMES FROM THE PUBLICATION INCLUDE: NO EARLY MORTALITY IN EITHER GROUP. THERE WERE TWO BLEEDING EVENTS IN THE OLD-VALVE GROUP; NONE IN THE NEW-VALVE GROUP. THERE WAS ONE PACEMAKER INSERTION IN THE OLD-VALVE GROUP AND TWO PACEMAKER INSERTIONS IN THE NEW-VALVE GROUP. THERE WERE 28 LATE DEATHS IN BOTH GROUPS IN TOTAL. THE CAUSES OF DEATH INCLUDED THREE WITH CEREBRAL HEMORRHAGE IN, TWO WITH CEREBRAL INFARCTION, ONE WITH ALVEOLAR HEMORRHAGE, ONE WITH HEART FAILURE, ONE WITH ISCHEMIC CARDIOMYOPATHY, ONE WITH SUDDEN DEATH, SIX WITH CANCER, ONE WITH AGING, AND TEN UNKNOWN. THERE WAS A TOTAL OF SIX REOPERATIONS.
ACCORDING TO THE PUBLICATION "LATE CLINICAL OUTCOMES AFTER MECHANICAL AORTIC VALVE REPLACEMENT FOR AORTIC STENOSIS (AS): OLD VERSUS NEW PROSTHESES" BY PYO WON PARK, HEEMOON LEE, KIICK SUNGA, ET. AL., A COMPARATIVE STUDY WAS CONDUCTED TO EVALUATE THE LATE CLINICAL OUTCOMES OF NEW-GENERATION MECHANICAL VALVES FOR SEVERE AORTIC STENOSIS COMPARED WITH OLD MECHANICAL VALVES. DATA WAS RETROSPECTIVELY STUDIED FROM 254 PATIENTS WITH AS WHO UNDERWENT PRIMARY MECHANICAL AORTIC VALVE REPLACEMENT FROM 1995 TO 2013. PATIENTS WERE PLACED INTO TWO GROUPS CLASSIFIED AS ¿OLD-VALVE GROUP¿ AND ¿NEW-VALVE GROUP.¿ THE OLD-VALVE GROUP CONSISTED OF 65 RECIPIENTS RECEIVING 33 ATS STANDARD VALVES AND 32 MEDTRONIC-HALL VALVES. THE NEW VALVE GROUP CONSISTED OF 189 RECIPIENTS RECEIVING 113 ST. JUDE REGENT VALVES, 46 ON-X VALVES, AND 30 SORIN OVERLINE VALVES. SUMMARY OF THE OUTCOMES FROM THE PUBLICATION INCLUDE: NO EARLY MORTALITY IN EITHER GROUP. THERE WERE TWO BLEEDING EVENTS IN THE OLD-VALVE GROUP; NONE IN THE NEW-VALVE GROUP. THERE WAS ONE PACEMAKER INSERTION IN THE OLD-VALVE GROUP AND TWO PACEMAKER INSERTIONS IN THE NEW-VALVE GROUP. THERE WERE 28 LATE DEATHS IN BOTH GROUPS IN TOTAL. THE CAUSES OF DEATH INCLUDED THREE WITH CEREBRAL HEMORRHAGE IN, TWO WITH CEREBRAL INFARCTION, ONE WITH ALVEOLAR HEMORRHAGE, ONE WITH HEART FAILURE, ONE WITH ISCHEMIC CARDIOMYOPATHY, ONE WITH SUDDEN DEATH, SIX WITH CANCER, ONE WITH AGING, AND TEN UNKNOWN. THERE WAS A TOTAL OF SIX REOPERATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771854 | ON-X AORTIC VALVE UNKNOWN CONFIGURATION | HEART-VALVE, MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES | ONXA UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| O |