ONX MITRAL CONFORM 25/33
Report
- Report Number
- 1649833-2025-00036
- Event Type
- Injury
- Date Received
- October 6, 2025
- Date of Event
- September 25, 2025
- Report Date
- December 31, 2025
- Manufacturer
- ARTIVION, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A SAMPLE EVALUATION WAS PERFORMED. THIS VALVE (ONXMC-25/33, SERIAL NUMBER (B)(6)) WAS RETURNED WITH THE ALLEGATION OF A CRACKED LEAFLET DURING IMPLANTATION. ACCORDING TO THE INITIAL REPORT RECEIVED ON (B)(6) 2025 FROM ARTIVION SENIOR SPECIALIST, RAQA, APAC, A JAPANESE HOSPITAL REPORTED THAT DURING USE OF AN ON-X MITRAL CONFORM AT (B)(6), A SINGLE LEAFLET CRACKED. ADDITIONAL INFORMATION INDICATED THAT, WHILE PASSING THE WOUND RETRACTOR, THE VALVE WAS REMOVED FROM THE HOLDER, A FINGER WAS INSERTED INTO THE GAP BETWEEN THE LEAFLET AND THE ORIFICE (HORSESHOE-SHAPED OPENING), AND THE LEAFLET BROKE WHEN THE VALVE WAS PUSHED INTO THE THORACIC CAVITY. RADIOGRAPHIC IMAGING WAS USED INTRAOPERATIVELY TO SEARCH FOR FRAGMENTS; NOT ALL FRAGMENTS WERE FOUND, AND IT WAS NOTED THAT BROKEN FRAGMENTS MAY HAVE BEEN ASPIRATED DURING EXTRACORPOREAL CIRCULATION. PRIOR TO DECONTAMINATION, VISUAL EXAMINATION OF THE RETURNED VALVE REVEALED ONE LEAFLET HAD FRACTURED. THE RETURNED LEAFLET FRAGMENTS WERE PIECED TOGETHER DURING EVALUATION; HOWEVER, NOT ALL PORTIONS OF THE FRACTURED LEAFLET WERE RETURNED. SEM SCANS OF THE FRACTURED LEAFLET FRAGMENTS FOUND MULTIPLE LOCATIONS CONTAINING METALLIC ARTIFACTS. THE ARTIFACTS CONTAINED IRON, ALUMINUM, CHROMIUM, NICKEL, AND MAGNESIUM ELEMENTS. THESE IDENTIFIED ELEMENTS ARE COMMON IN SURGICAL STEEL AND ALLOYS USED IN INSTRUMENTATION. BECAUSE OF THESE POINTS, AND THE REPORTED MANIPULATION OF THE VALVE (REMOVAL FROM THE HOLDER AND INSERTION OF A FINGER BETWEEN THE LEAFLET AND THE ORIFICE), THE LEAFLET FRACTURE APPEARS TO BE THE RESULT OF DIRECT CONTACT WITH A METALLIC INSTRUMENT AND INAPPROPRIATE MANUAL HANDLING OF THE CARBON SURFACES. THE LEAFLET BREAKAGE APPEARS TO BE RELATED TO FORCES GENERATED BY CONTACT AND MANIPULATION WITH A METALLIC INSTRUMENT AND MANUAL HANDLING. THE ON-X HEART VALVE IFU, 010122 77 [E], STATES THE FOLLOWING PRECAUTION: ¿AVOID CONTACTING THE CARBON SURFACES OF THE VALVE WITH GLOVED FINGERS OR ANY METALLIC OR ABRASIVE INSTRUMENTS AS THEY MAY CAUSE DAMAGE TO THE VALVE SURFACE...¿ THE AVAILABLE INFORMATION AND ANALYTICAL FINDINGS INDICATE THAT THIS EVENT IS CONSISTENT WITH MISUSE/USE-RELATED DAMAGE RATHER THAN A MANUFACTURING DEFECT. THE MANUFACTURING RECORDS FOR ONXMC-25/33 SN (B)(6) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. CHANGE ORDER (LE 18903) FOR LEAFLET TUNING ARE PERFORMED AS A PART OF THE STANDARD MANUFACTURING PROCESS. ON (B)(6) 2025, A COMPLAINT OF A CRACKED LEAFLET WAS REPORTED TO ARTIVION BY A (B)(6) HOSPITAL, AND AN INVESTIGATION WAS INITIATED FOR AN ONXMC-25/33 MITRAL HEART VALVE, SERIAL NUMBER (B)(6), USED DURING A MINIMALLY INVASIVE MITRAL VALVE REPLACEMENT PROCEDURE AT KITAHARIMA GENERAL MEDICAL CENTER. THE VALVE WAS IMPLANTED IN THE MITRAL POSITION DURING A LAPAROSCOPIC MINIMALLY INVASIVE CARDIAC SURGERY (MICS). ACCORDING TO THE REPORT, WHILE PASSING THE WOUND RETRACTOR, THE VALVE WAS REMOVED FROM THE HOLDER AND A FINGER WAS INSERTED INTO THE GAP BETWEEN THE LEAFLET AND THE ORIFICE (HORSESHOE-SHAPED OPENING). DURING INSERTION INTO THE THORACIC CAVITY, A SINGLE LEAFLET CRACKED. INTRAOPERATIVE RADIOGRAPHIC IMAGING WAS USED TO SEARCH FOR LEAFLET FRAGMENTS; HOWEVER, NOT ALL FRAGMENTS WERE RECOVERED, AND IT WAS NOTED THAT BROKEN FRAGMENTS MAY HAVE BEEN ASPIRATED DURING EXTRACORPOREAL CIRCULATION. THE MITRAL VALVE REPLACEMENT WAS COMPLETED USING AN ON-X STANDARD M23 VALVE, AS NO STANDBY INVENTORY WAS AVAILABLE AT THE TIME OF SURGERY. THE AFFECTED ONXMC-25/33 VALVE WAS RETURNED TO ARTIVION FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED VALVE CONFIRMED THAT ONE LEAFLET HAD FRACTURED. RETURNED LEAFLET FRAGMENTS WERE PIECED TOGETHER DURING EVALUATION; HOWEVER, NOT ALL PORTIONS OF THE FRACTURED LEAFLET WERE RETURNED. SCANNING ELECTRON MICROSCOPY (SEM) AND ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS OF THE FRACTURED LEAFLET FRAGMENTS IDENTIFIED METALLIC ARTIFACTS CONTAINING IRON, ALUMINUM, CHROMIUM, NICKEL, AND MAGNESIUM. THESE ELEMENTS ARE COMMONLY FOUND IN SURGICAL STEEL AND ALLOYS USED IN SURGICAL INSTRUMENTATION. THE LEAFLET BREAKAGE APPEARS TO BE RELATED TO FORCES GENERATED BY CONTACT AND MANIPULATION WITH A METALLIC INSTRUMENT AND MANUAL HANDLING. THE IFU STATES: ¿AVOID CONTACTING THE CARBON SURFACES OF THE VALVE WITH GLOVED FINGERS OR ANY METALLIC OR ABRASIVE INSTRUMENTS AS THEY MAY CAUSE DAMAGE TO THE VALVE SURFACE¿¿ BASED ON THE REPORTED CIRCUMSTANCES OF VALVE HANDLING DURING IMPLANTATION AND THE OBSERVATIONS MADE DURING DEVICE EVALUATION, THE LEAFLET FRACTURE IS MOST CONSISTENT WITH CONTACT AND MANIPULATION OF THE VALVE DURING THE MINIMALLY INVASIVE PROCEDURE. THE AVAILABLE INFORMATION SUGGESTS THAT HANDLING OF THE VALVE FOLLOWING REMOVAL FROM THE HOLDER MAY HAVE CONTRIBUTED TO THE EVENT, AND THE FINDINGS ARE NOT INDICATIVE OF A MANUFACTURING DEFECT. THIS INVESTIGATION SUPPORTS A CONCLUSION OF USE-RELATED DAMAGE CONSISTENT WITH RISKS AND PRECAUTIONS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE RISK FILE WAS REVIEWED, AND IT THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS FAR AS POSSIBLE BY DESIGN AND PROCESS. POST-PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT¿S LABELING AND IFU (INSTRUCTIONS FOR USE). BASED ON THE REPORTED CIRCUMSTANCES OF VALVE HANDLING DURING IMPLANTATION AND THE OBSERVATIONS MADE DURING DEVICE EVALUATION, THE LEAFLET FRACTURE IS MOST CONSISTENT WITH CONTACT AND MANIPULATION OF THE VALVE DURING THE MINIMALLY INVASIVE PROCEDURE. THE AVAILABLE INFORMATION SUGGESTS THAT HANDLING OF THE VALVE FOLLOWING REMOVAL FROM THE HOLDER MAY HAVE CONTRIBUTED TO THE EVENT, AND THE FINDINGS ARE NOT INDICATIVE OF A MANUFACTURING DEFECT. THIS INVESTIGATION SUPPORTS A CONCLUSION OF USE-RELATED DAMAGE CONSISTENT WITH RISKS AND PRECAUTIONS DESCRIBED IN THE INSTRUCTIONS FOR USE. A PRODUCT FAILURE IS NOT IDENTIFIED; THUS, SEVERITY AND OCCURRENCE ARE NOT EVALUATED. THIS DEVICE WAS RETURNED FOR ANALYSIS. BASED ON THE REPORTED CIRCUMSTANCES OF VALVE HANDLING DURING IMPLANTATION AND THE OBSERVATIONS MADE DURING DEVICE EVALUATION, THE LEAFLET FRACTURE IS MOST CONSISTENT WITH CONTACT AND MANIPULATION OF THE VALVE DURING THE MINIMALLY INVASIVE PROCEDURE. THE AVAILABLE INFORMATION SUGGESTS THAT HANDLING OF THE VALVE FOLLOWING REMOVAL FROM THE HOLDER MAY HAVE CONTRIBUTED TO THE EVENT, AND THE FINDINGS ARE NOT INDICATIVE OF A MANUFACTURING DEFECT. THIS INVESTIGATION SUPPORTS A CONCLUSION OF USE-RELATED DAMAGE CONSISTENT WITH RISKS AND PRECAUTIONS DESCRIBED IN THE INSTRUCTIONS FOR USE. MANUFACTURING RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION- FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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.
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 IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT RECEIVED, (B)(6) 2025, DURING THE USE OF AN ONX CONFORM M VALVE VIA LAPAROSCOPIC MICS AT KITAHARIMA GENERAL MEDICAL CENTER C A SINGLE LEAFLET CRACKED. ·ALTHOUGH X-RAYS WERE USED DURING SURGERY TO SEARCH FOR FRAGMENTS, NOT ALL WERE FOUND. IT WAS DETERMINED NO FRAGMENTS REMAINED INSIDE THE PATIENT. ·THE MVR WAS PERFORMED USING AN ON-X STANDARD M23 VALVE (BROUGHT SPECIFICALLY FOR THE ON-XMC-25/33 PROCEDURE) AND THE OPERATION WAS COMPLETED. ·ALTHOUGH NOT ALL FRAGMENTS WERE FOUND, IT CANNOT BE RULED OUT THAT BROKEN FRAGMENTS MAY HAVE BEEN ASPIRATED DURING EXTRACORPOREAL CIRCULATION. ·THE OPERATING SURGEON HAS EXTENSIVE EXPERIENCE USING ON-X VALVES, PRIMARILY FOR AORTIC VALVES. THIS WAS HIS SECOND CASE INVOLVING A MITRAL VALVE. ·DURING MINIMALLY INVASIVE CARDIAC SURGERY (MICS), WHILE PASSING THE WOUND RETRACTOR, THE ON-X WAS REMOVED FROM THE HOLDER. A FINGER WAS INSERTED INTO THE GAP BETWEEN THE LEAFLET AND THE ORIFICE (A HORSESHOE-SHAPED OPENING). AND IT BROKE WHEN HE PUSHED IT INTO THE THORACIC CAVITY. THIS INVESTIGATION IS RELEGATED TO ONXMC-25/33 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF CRACKED LEAFLET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2478065 | ONX MITRAL CONFORM 25/33 | HEART-VALVE, MECHANICAL | LWQ | ARTIVION, INC. | ONXMC-25/33 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| L |