ON-X MITRAL VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2017-00083
- Event Type
- Death
- Date Received
- November 14, 2017
- Report Date
- January 8, 2018
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. A SINGLE CENTER RETROSPECTIVE REVIEW OF ITS 58 REDO MITRAL VALVE REPLACEMENT CASES BETWEEN JANUARY 2005 AND DECEMBER 2014. AS ALL OF THESE ARE REDO'S, ALL OF THEM PRESENT PROBLEMS NECESSITATING THE RE-OPERATION. IT IS A SPECIALIZED SUBSET OF RECORDS. HOWEVER, WE DO NOT HAVE A PERSPECTIVE ON HOW THIS GROUP FITS INTO THE CENTER'S OVERALL IMPLANT RECORD NOR ITS SIGNIFICANCE TO THE GENERAL MVR POPULATION. NOR ARE WE ABLE TO ESTABLISH HOW MANY OF THE CASES ARE RELATED TO THE ON-X VALVE OTHER THAN THAT IT WAS "THE MOST COMMONLY USED." NEVERTHELESS, THE REVIEW DOES HAVE SOME CHARACTERISTICS OF NOTE. THE PATIENT DEMOGRAPHICS SHOW A MALE:FEMALE RATIO OF 1:3. THEY ALSO SHOW THAT THE AVERAGE INR WAS 1.96 (AHA/ACC RECOMMENDS INR OF 2.5-3.5 WITH DAILY 70-100 MG ASPIRIN FOR MECHANICAL MITRAL VALVES [NISHIMURA 2014)) AND COMPLIANCE PRIOR TO SURGERY WAS REPORTED IN 71% OF THE PATIENTS, WHICH MEANS 29% WERE NON-COMPLIANT. 31 PATIENTS (54%) WERE DIAGNOSED WITH VALVE THROMBOSIS. AS THE AUTHORS NOTED, THE AVERAGE AGE WAS 32 ± 15.81 YEARS, WHICH IS YOUNGER THAN THE WORLD LITERATURE WOULD SUGGEST. THE LEADING CAUSE UNDERLYING MITRAL VALVE REPLACEMENT WAS RHEUMATIC FEVER. IT IS ALSO NOTED THAT THE MEAN DURATION BETWEEN FIRST AND REDO SURGERY WAS 8.8 YEARS AND THAT NONE OF THE REDO'S REPORTED WERE DUE TO A LACK OF VALVE DURABILITY. FINALLY, THE MORTALITY RATE WAS CONSIDERED NEGLIGIBLE (ALTHOUGH 2 PATIENTS DIED POSTOPERATIVELY). ALL OF THESE ADVERSE EVENT OBSERVATIONS ARE EXPECTED [INSTRUCTIONS FOR USE (IFU)], ALTHOUGH THE FREQUENCY OF OCCURRENCE IS DIFFICULT TO CORRELATE WITH REST-OF-THE-WORLD EXPERIENCE. CONSEQUENTLY, WE CANNOT MAKE ANY JUDGMENT ON ON-X VALVE PERFORMANCE RELATIVE TO EXPECTATIONS AS WE HAVE NO QUANTITATIVE COMPARATORS UPON WHICH TO BASE ANY CONCLUSIONS. THE FOLLOWING ADVERSE EVENTS ARE LISTED IN THE IFU. AS NOTED, ANY NUMBER OF THE FOLLOWING ADVERSE EVENTS COULD LEAD TO REOPERATION AND EXPLANTATION .SEE EXCERPT FROM THE IFU BELOW. HTTP://WWW.ONXLTI.COM/IFU/HV/, ¿5. POTENTIAL ADVERSE EVENTS - ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH THE USE OF PROSTHETIC HEART VALVES (IN ALPHABETICAL ORDER) INCLUDE, BUT ARE NOT LIMITED TO: ANGINA, CARDIAC ARRHYTHMIA, ENDOCARDITIS, HEART FAILURE, HEMOLYSIS, HEMOLYTIC ANEMIA, HEMORRHAGE, MYOCARDIAL INFARCTION, PROSTHESIS LEAFLET ENTRAPMENT (IMPINGEMENT), PROSTHESIS NONSTRUCTURAL DYSFUNCTION, PROSTHESIS PANNUS, PROSTHESIS PERIVALVULAR LEAK, PROSTHESIS REGURGITATION, PROSTHESIS STRUCTURAL DYSFUNCTION, PROSTHESIS THROMBOSIS, STROKE, THROMBOEMBOLISM.¿ IT IS POSSIBLE THAT THESE COMPLICATIONS COULD LEAD TO: REOPERATION, EXPLANTATION, PERMANENT DISABILITY, DEATH. THE ARTICLE DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. WITH THE DATA PRESENTED, WE CANNOT SAY WHAT, OR HOW MUCH, IF ANY, CONTRIBUTION THE ON-X VALVES HAD TO THE EVENTS NECESSITATING REOPERATIONS. ROOT CAUSE FOR THIS INFORMATION IS UNKNOWN. NO FURTHER ACTION IS WARRANTED AT THIS TIME.
ACCORDING TO THE ARTICLE "MANAGEMENT OF FAILED MITRAL VALVE REPLACEMENT. THE DURBAN EXPERIENCE". "FIFTY-EIGHT PATIENTS WERE DOCUMENTED. PRESENTING FEATURES AT REDO SURGERY WERE CONGESTIVE CARDIAC FAILURE (27), CHEST PAIN (11) AND PALPITATIONS (17). MEAN PREOPERATIVE EJECTION FRACTION WAS 51.65 %. TWENTY-NINE PATIENTS (55%) HAD EMERGENCY REDO SURGERY. TWENTY-TWO PATIENTS (75%) HAD ACUTE PROSTHETIC VALVE THROMBOSIS. THIRTY-TWO PATIENTS HAD TRICUSPID REGURGITATION. ORIGINAL PATHOLOGY WAS DOCUMENTED IN 23 PATIENTS (40%) AS RHEUMATIC VALVE DISEASE. PROSTHETIC VALVE THROMBOSIS WAS DOCUMENTED IN 31 PATIENTS (54%). THE MOST COMMONLY USED VALVE WAS THE ON-X. MEAN PRESENTING INR WAS 1.96 + 1.2 AND MEAN PRESENTING SERUM ALBUMIN WAS 36.7 + 7.8 G/I. FORTY-ONE PATIENTS (71%) WERE FOUND TO BE COMPLIANT TO WARFARIN THERAPY PRIOR TO REDO SURGERY . TWO PATIENTS DIED POSTOPERATIVELY. TWELVE PATIENTS (20.7%) DEVELOPED POSTOPERATIVE COMPLICATIONS. RHEUMATIC HEART DISEASE WAS THE COMMON UNDERLYING PATHOLOGY. PROSTHETIC VALVE THROMBOSIS WAS COMMON. MORE THAN HALF HAD EMERGENCY SURGERY. MORTALITY RATE WAS NEGLIGIBLE."
ACCORDING TO THE ARTICLE "MANAGEMENT OF FAILED MITRAL VALVE REPLACEMENT. THE DURBAN EXPERIENCE". "FIFTY-EIGHT PATIENTS WERE DOCUMENTED. PRESENTING FEATURES AT REDO SURGERY WERE CONGESTIVE CARDIAC FAILURE (27), CHEST PAIN (11) AND PALPITATIONS (17). MEAN PREOPERATIVE EJECTION FRACTION WAS 51.65 %. TWENTY-NINE PATIENTS (55%) HAD EMERGENCY REDO SURGERY. TWENTY-TWO PATIENTS (75%) HAD ACUTE PROSTHETIC VALVE THROMBOSIS. THIRTY-TWO PATIENTS HAD TRICUSPID REGURGITATION. ORIGINAL PATHOLOGY WAS DOCUMENTED IN 23 PATIENTS (40%) AS RHEUMATIC VALVE DISEASE. PROSTHETIC VALVE THROMBOSIS WAS DOCUMENTED IN 31 PATIENTS (54%). THE MOST COMMONLY USED VALVE WAS THE ON-X. MEAN PRESENTING INR WAS 1.96 + 1.2 AND MEAN PRESENTING SERUM ALBUMIN WAS 36.7 + 7.8 G/I. FORTY-ONE PATIENTS (71%) WERE FOUND TO BE COMPLIANT TO WARFARIN THERAPY PRIOR TO REDO SURGERY . TWO PATIENTS DIED POSTOPERATIVELY. TWELVE PATIENTS (20.7%) DEVELOPED POSTOPERATIVE COMPLICATIONS. RHEUMATIC HEART DISEASE WAS THE COMMON UNDERLYING PATHOLOGY. PROSTHETIC VALVE THROMBOSIS WAS COMMON. MORE THAN HALF HAD EMERGENCY SURGERY. MORTALITY RATE WAS NEGLIGIBLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808807 | ON-X MITRAL VALVE UNKNOWN CONFIGURATION | HEART VALVE MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXM UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| L| O| R| S |