ON-X PROSTHETIC VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2024-00062
- Event Type
- Injury
- Date Received
- November 1, 2024
- Report Date
- December 13, 2024
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
THE PUBLICATION ¿MITRAL AND AORTIC VALVE PROSTHETIC ENDOCARDITIS AFTER PERCUTANEOUS CLOSURE OF MITRAL PARAVALVULAR LEAK¿ BY MALVINDI, ET AL PUBLISHED BY THE ANNALS OF THORACIC SURGERY IN 2013 IS REVIEWED HERE. THIS PUBLICATION REPORTS ON A 67-YEAR-OLD MALE PATIENT WHO WAS IMPLANTED WITH AN ON-X AORTIC VALVE SIZE 25MM AND AN ON-X MITRAL VALVE SIZE 21MM IN 2002. IN 2008 (6 YEARS POST IMPLANT) HE PRESENTED WITH SYMPTOMS OF DYSPNEA AND HEMOLYTIC ANEMIA AND DIAGNOSED WITH A LARGE ANTERIOR MITRAL PARAVALVULAR LEAK WITH SEVERE REGURGITATION. IN (B)(6) 2009 HE WAS ADMITTED AND UNDERWENT PERCUTANEOUS CLOSURE OF A PERIPROSTHETIC LEAK WITH AN AMPLATZER DUCT OCCLUDER DEVICE. THE PREDISCHARGE ECHOCARDIOGRAM SHOWED MODERATE PARAVALVULAR REGURGITATION. A FEW DAYS LATER, THE PATIENT EXPERIENCED NEW ONSET OF SYMPTOMS THAT INCLUDED CONGESTIVE HEART FAILURE AND HEMOLYTIC ANEMIA. TWO MONTHS LATER, FEVER DEVELOPED, AND BLOOD SAMPLES SHOWED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. HE UNDERWENT TRANSESOPHAGEAL EXAMINATION, WHICH DEMONSTRATED PARTIAL MITRAL PROSTHESIS DETACHMENT, THE PRESENCE OF AN EXTENDED SEPTIC THROMBUS CAUSING MITRAL PROSTHESIS LEAFLET OBSTRUCTION, AND AN ANNULAR ABSCESS EXTENDING TOWARD THE AORTIC ANNULUS. THE SAME DAY HE UNDERWENT REOPERATION FOR MITRAL AND AORTIC MECHANICAL PROSTHESIS REPLACEMENT , WITH PARTIAL RECONSTRUCTION OF THE FIBROUS SKELETON WITH HETEROLOGOUS PERICARDIUM. AT OPERATION, THE MITRAL PROSTHESIS TURNED OUT TO BE COMPLETELY DETACHED AT THE ANTERIOR ANNULAR PORTION AND WAS REMOVED BY SIMPLY PULLING THE SEWING RING. A GIANT VEGETATION INVOLVED THE PROSTHESIS AND THE OCCLUDER DEVICE, WHICH HAD UNDERGONE INCOMPLETE ENDOTHELIALIZATION AND APPEARED TO BE FILLED WITH VEGETATIONS AND THROMBOTIC MATERIAL. THE AORTOMITRAL CURTAIN WAS INFILTRATED AND PARTIALLY DESTROYED, A SUBANNULAR ABSCESS WAS PRESENT AT THE INTERVENTRICULAR SEPTUM, AND THE AORTIC PROSTHESIS WAS COMPLETELY DETACHED AT THE NONCORONARY SINUS . THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY FOR 6 WEEKS. TRANSTHORACIC ECHOCARDIOGRAPHY AT HOSPITAL DISCHARGE AND 4 MONTHS LATER SHOWED GOOD FUNCTIONING OF BOTH VALVULAR PROSTHESES, WITH NO EVIDENCE OF PARAVALVULAR LEAK. THE VALVE WAS NOT RETURNED FOR INSPECTION AND NO MEDICAL RECORDS WERE PROVIDED AND DESPITE MULTIPLE ATTEMPTS TO CONTACT THE AUTHORS NO RESPONSE WAS RECEIVED. THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE ACKNOWLEDGE PARAVALVULAR LEAK AS A POTENTIAL COMPLICATION FOLLOWING PROSTHETIC VALVE REPLACEMENT, WHICH MAY LEAD TO REOPERATION AS WELL AS EXPLANTATION [IFU]. HISTORICALLY, MAJOR PARAVALVULAR LEAK OCCURS AT A RATE OF (B)(4) PER PATIENT-YEAR FOR MITRAL RIGID HEART SUBSTITUTES [ISO 5840-2:2021(E)]. THE INSTRUCTIONS FOR USE (IFU) FOR THE ON-X VALVE STATES THAT ENDOCARDITIS IS A KNOWN POTENTIAL EVENT ACKNOWLEDGED IN THE IFU. THOUGH RARE, HISTORICALLY, ENDOCARDITIS OCCURS AT A RATE OF 0.3 %/PATIENT-YEAR FOR BOTH MECHANICAL AORTIC AND MITRAL HEART VALVES [ISO 5840-2:2021]. ALTHOUGH, IN THIS CASE THE ENDOCARDITIS IS MOST LIKELY CONNECTED TO THE PERCUTANEOUS CLOSURE OF THE PVL AS THE SYMPTOMS OF ENDOCARDITIS (FEVER AND POSITIVE BLOOD CULTURES) BEGAN TWO MONTHS AFTER THAT PROCEDURE AND MORE THAN 6 YEARS FROM THE INITIAL IMPLANT OF THE ON-X AORTIC AND MITRAL VALVES. THE AUTHOR IDENTIFIED PVL AS THE ROOT CAUSE NECESSITATING THE PERCUTANEOUS CLOSURE; HOWEVER, THE LIMITED INFORMATION AVAILABLE AND ABSENCE OF MEDICAL RECORDS HINDER A DEFINITIVE CONCLUSION REGARDING THE UNDERLYING CAUSE OF THE PVL. THE MOST COMMON CAUSES OF PVL ARE SUTURE DEHISCENCE, ANNULAR CALCIFICATION AND/OR FRIABILITY, INFECTION, AND TECHNICAL ISSUES DURING SURGERY. GIVEN THE AVAILABLE INFORMATION, IT REMAINS UNCLEAR WHAT, IF ANY, CONTRIBUTION THE VALVE ITSELF HAD TO THE DEVELOPMENT OF THE PVL THAT LED TO THE EXPLANT. THE AUTHOR ALSO CONCLUDES THAT THERE WAS NO EVIDENCE THAT THE MITRAL PROSTHETIC LEAK WAS CAUSED BY ENDOCARDITIS. THE TIME CORRELATION BETWEEN THE PERCUTANEOUS PROCEDURE AND INFECTION MIGHT SUGGEST THAT THE INFECTIOUS PROCESS FOLLOWED THE PERCUTANEOUS CLOSURE WITH THE DUCT OCCLUDER. IN ADDITION TO THE TIMING OF THE INFECTION, WITH SYMPTOMS BEGINNING WITHIN DAYS OF THE PERCUTANEOUS CLOSURE AND MORE THAN 4 YEARS AFTER IMPLANTATION OF THE ON-X VALVE AND BECAUSE ALL ON-X VALVES UNDERGO VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION, THE VALVE IS UNLIKELY TO BE THE SOURCE OF THE INFECTION. THE RISK MANAGEMENT AND USABILITY ENGINEERING FILE WAS REVIEWED AND FOUND TO BE ADEQUATE. THERE IS INSUFFICIENT DATA TO DETERMINE A PRODUCT FAILURE MODE; THUS, SEVERITY AND OCCURRENCE IS NOT EVALUATED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
PUBLICATION ¿MITRAL AND AORTIC VALVE PROSTHETIC ENDOCARDITIS AFTER PERCUTANEOUS CLOSURE OF MITRAL PARAVALVULAR LEAK ¿ DR. MALVINDI ET AT. REPORTS ON A CASE OF A 67-YEAR-OLD MAN WHO PRESENTED WITH MASSIVE MITRAL AND AORTIC VALVE PROSTHETIC ENDOCARDITIS 2 MONTHS AFTER TRANSCATHETER PERCUTANEOUS CLOSURE OF A MITRAL PARAVALVULAR LEAK WITH A NON-ARTIVION DUCT OCCLUDER DEVICE. HE UNDERWENT SUCCESSFUL REOPERATION FOR VALVE PROSTHESIS REPLACEMENT AND RECONSTRUCTION OF THE ANTERIOR FIBROUS TRIGONE. IN 2002, A 67-YEAR-OLD MAN EXPERIENCED CONGESTIVE HEART FAILURE RESULTING FROM SEVERE MITRAL AND AORTIC REGURGITATION. HE UNDERWENT MITRAL AND AORTIC VALVE REPLACEMENT WITH MECHANICAL PROSTHESES (NO. 21 ON-X AORTIC VALVE, NO. 25 ON-X MITRAL VALVE; ON-X LIFE TECHNOLOGIES, INC, AUSTIN, TX) AT AN OUTSIDE FACILITY. IN 2008, AFTER THE ONSET OF DYSPNEA AND HEMOLYTIC ANEMIA, A LARGE ANTERIOR MITRAL PARAVALVULAR LEAK WITH SEVERE REGURGITATION WAS DIAGNOSED. IN (B)(6) 2009 HE WAS ADMITTED TO ANOTHER HOSPITAL AND UNDERWENT PERCUTANEOUS CLOSURE OF A PERIPROSTHETIC LEAK. THE PREDISCHARGE ECHOCARDIOGRAM SHOWED MODERATE PARAVALVULAR REGURGITATION. A FEW DAYS LATER, THE PATIENT EXPERIENCED NEW ONSET OF SYMPTOMS THAT INCLUDED CONGESTIVE HEART FAILURE AND HEMOLYTIC ANEMIA. TWO MONTHS LATER, FEVER DEVELOPED. BLOOD SAMPLES SHOWED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, AND FOR THIS REASON HE WAS TRANSFERRED TO OUR HOSPITAL. AT THE INTENSIVE CARE UNIT ADMISSION, HE UNDERWENT TRANSESOPHAGEAL EXAMINATION, WHICH DEMONSTRATED PARTIAL MITRAL PROSTHESIS DETACHMENT, THE PRESENCE OF AN EXTENDED SEPTIC THROMBUS CAUSING MITRAL PROSTHESIS LEAFLET OBSTRUCTION,AND AN ANNULAR ABSCESS EXTENDING TOWARD THE AORTIC ANNULUS. THE SAME DAY HE UNDERWENT REOPERATION FOR MITRAL AND AORTIC MECHANICAL PROSTHESIS REPLACEMENT WITH PARTIAL RECONSTRUCTION OF THE FIBROUS SKELETON WITH HETEROLOGOUS PERICARDIUM. AT OPERATION, THE MITRAL PROSTHESIS TURNED OUT TO BE COMPLETELY DETACHED AT THE ANTERIOR ANNULAR PORTION AND WAS REMOVED BY SIMPLY PULLING THE SEWING RING. A GIANT VEGETATION INVOLVED THE PROSTHESIS AND THE OCCLUDER DEVICE, WHICH HAD UNDERGONE INCOMPLETE ENDOTHELIALIZATION AND APPEARED TO BE FILLED WITH VEGETATIONS AND THROMBOTIC MATERIAL. THE AORTOMITRAL CURTAIN WAS INFILTRATED AND PARTIALLY DESTROYED, A SUBANNULAR ABSCESS WAS PRESENT AT THE INTERVENTRICULAR SEPTUM, AND THE AORTIC PROSTHESIS WAS COMPLETELY DETACHED AT THE NONCORONARY SINUS. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY FOR THE ENSUING 6 WEEKS. TRANSTHORACIC ECHOCARDIOGRAPHY AT HOSPITAL DISCHARGE AND 4 MONTHS LATER SHOWED GOOD FUNCTIONING OF BOTH VALVULAR PROSTHESES, WITH NO EVIDENCE OF PARAVALVULAR LEAK. IN THE CASE PRESENTED, THERE WAS NO EVIDENCE THAT THE MITRAL PROSTHETIC LEAK WAS CAUSED BY ENDOCARDITIS. THE TIME CORRELATION BETWEEN THE PERCUTANEOUS PROCEDURE AND INFECTION MIGHT SUGGEST THAT THE INFECTIOUS PROCESS FOLLOWED THE DUCT OCCLUDER IMPLANTATION AND COULD HAVE BEEN PROMOTED BY THE SUBOPTIMAL TECHNICAL RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 790799 | ON-X PROSTHETIC VALVE UNKNOWN CONFIGURATION | HEART-VALVE, MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONX UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Other |