On-X Ascending Aortic Prosthesis ONXAAP-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00851788001532), received between Nov 6, 2015 and May 13, 2025 — classified as 2 deaths, 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (P000037); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORTS FROM (B)(6), PRODUCT TRACKING ASSOCIATE, ARTIVION, INC., "RECEIVED A HOSPITAL REPORT INDICATING IMPLANT HAD BEEN EXPLANTED AND REPLACED." ONXAAP-27/29 (B)(6). IMPLANT DATE (B)(6) 2024. EXPLANT DATE (B)(6) 2025. THIS INVESTIGATION IS RELEGATED TO ONXAAP-27/29, (B)(6) FOR EXPLANT. ADDITIONAL INFORMATION: PRE-OPERATIVE DIAGNOSIS 1. PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH LIKELY INFECTED ASCENDING DACRON GRAFT. 2. STATUS POST REDO STERNOTOMY AND DEBRIDEMENT OF PREVIOUS AORTIC VALVE REPLACEMENT WITH ROOT REPLACEMENT IN (B)(6) 2024. 3. STATUS POST AVR WITH TISSUE PROSTHESIS AS WELL AS MITRAL VALVE REPAIR WITH ANNULOPLASTY RING IN 2019. 4. DEVELOPMENT OF COMPLETE HEART BLOCK REQUIRING INSERTION OF A TEMPORARY PERMANENT PACING SYSTEM, LIKELY SECONDARY TO PROGRESSION OF ROOT ABSCESS. POST-OPERATIVE DIAGNOSIS 1. PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH LIKELY INFECTED ASCENDING DACRON GRAFT. 2. STATUS POST REDO STERNOTOMY AND DEBRIDEMENT OF PREVIOUS AORTIC VALVE REPLACEMENT WITH ROOT REPLACEMENT IN (B)(6) 2024. 3. STATUS POST AVR WITH TISSUE PROSTHESIS AS WELL AS MITRAL VALVE REPAIR WITH AN ANNULOPLASTY RING IN 2019. 4. DEVELOPMENT OF COMPLETE HEART BLOCK REQU

  Patient problems: Endocarditis; Heart Block

  MAUDE report 22009531 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL EMAIL ON (B)(6) 2024, "ATTACHED YOU WILL FIND A NEW AE REGARDING ON-X AND THE ASCEND STUDY." SOURCE DOCUMENTATION STATES PATIENT IN THE ASCEND STUDY EXPERIENCED CARDIAC ARRYTHMIA THAT LED TO HOSPITALIZATION BEGINNING ON (B)(6) 2023 AND RESOLVING (B)(6) 2023.

  Patient problems: Arrhythmia

  MAUDE report 21035515 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT RECEIVED VIA EMAIL ON 25JULY2024 FROM ARTIVION HECHINGEN COMPLAINT MANAGER, (B)(4)., ASCEND STUDY PATIENT (B)(6) EXPERIENCED ENDOCARDITIS WITH INFECTION.

  Patient problems: Endocarditis

  MAUDE report 20047109 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT RECEIVED VIA EMAIL ON 25JULY2024 FROM ARTIVION HECHINGEN COMPLAINT MANAGER, (B)(4)., ASCEND STUDY PATIENT (B)(6) EXPERIENCED VALVE THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20047056 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL NOTIFICATION "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2018 WITH A PREFABRICATED AAP DEVICE SN (B)(6). ON (B)(6) 2018 (1 DAY POST IMPLANT) WAS NOTED WITH MINIMAL RESPONSE AFTER SURGERY. THE SUBJECT¿S RELEVANT HISTORY IS AS FOLLOWS. THE SUBJECT HAS BEEN PREVIOUSLY ADMITTED IN (B)(6) 2018 DUE TO ISCHEMIC STROKE IN THE RIGHT CEREBELLUM DUE TO EMBOLISM FROM THROMBOSIS OF A MECHANICAL AORTIC VALVE. HE WAS DISCHARGED TO REHAB AND THEN READMITTED ON (B)(6) 2018. AN MRI PERFORMED ON (B)(6) 2018 SHOWED MULTIPLE NEW FOCI OF DIFFUSION RESTRICTION INTRACRANIALLY IN BOTH HEMISPHERES COMPATIBLE WITH NEW INTERVAL EMBOLIC PHENOMENON COMPARED TO (B)(6) 2018 STUDY. A TEE WAS PERFORMED (DATE UNKNOWN) SHOWING ANNULAR THROMBOSIS AND UNROOFING WITH A MOBILE MASS WITH A THIN STALK IN THE LVOT COMING FROM THE ANNULUS. THE RE-DO AORTIC VALVE REPAIR WITH ASCENDING AORTIC REPLACEMENT WAS DONE ON (B)(6) 2018. ON (B)(6) 2018 A REPEAT MRI WAS PERFORMED SHOWING SMALL PROBABLE ACUTE ISCHEMIC FOCUS INVOLVING POSTERIOR RIGHT OCCIPITAL LOBE THAT WAS NOT VISUALIZED ON PRIOR CT OR M

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 18594851 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL NOTIFICATION "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2014 WITH A PREFABRICATED AAP DEVICE SN (B)(6). ON (B)(6) 2018 (1,324 DAYS POST IMPLANT) AND PRESENTED TO THE ED FROM WORK WHERE HE EXPERIENCED DIFFICULTY FORMING WORDS, SLURRED SPEECH, RIGHT SIDED HEADACHE AND LEFT FACIAL DROOP. ALL SYMPTOMS HAD RESOLVED QUICKY PRIOR TO ARRIVING TO THE ED, EXCEPT LIGHT HEADINESS AND DIZZINESS. HE WAS ADMITTED FOR OBSERVATION AND FURTHER TESTING. AN MRI WAS PERFORMED SHOWING ACUTE INFARCT INVOLVING THE INSULAR CORTEX EXTENDING TO INVOLVE THE SUPERIOR LONGITUDINAL FASCICULAR ON THE RIGHT. THE CT AND CTA OF THE HEAD WERE UNREMARKABLE, THE CAROTID DOPPLER WAS UNREMARKABLE. INR WAS 2.0 ON ADMISSION. PT WAS EVALUATED BY PT/OT/ST AND DISCHARGED HOME ON (B)(6) 2018 AFTER ADDING ASA TO HIS DAILY MEDICATION TO FOLLOW UP WITH CARDIOLOGIST AND NEUROLOGIST." THIS COMPLAINT IS ASSOCIATED WITH ONXAAP-25 SN (B)(6).

  Patient problems: Stroke/CVA

  MAUDE report 18594801 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT IS SUBJECT #(B)(6) IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2013 WITH A PREFABRICATED AAP DEVICE SN #(B)(6). ON (B)(6) 2019 (1,961 DAYS POST IMPLANT) PRESENTED TO THE ED WITH COMPLAINTS OF RIGHT LOWER EXTREMITY WEAKNESS WITH ONSET OF SYMPTOMS AROUND 0930 THE DAY OF ASSESSMENT AND LASTED APPROXIMATELY 2 HOURS. HE PRESENTED FIRST TO A LOCAL ED WHERE A HEAD CT WAS PERFORMED WITH NEGATIVE RESULTS AND IT WAS RECOMMENDED, HE BE TRANSFERRED TO AN INCREASED LEVEL OF CARE FOR AN MRI AND LP, THE PATIENT REFUSED AND LEFT AMA. HE THEN LATER PRESENTED TO THE REFERRED ED AND WAS EVALUATED AGAIN, HE STATED HIS SYMPTOMS HAD RESOLVED HE WAS ADMITTED FOR OBSERVATION AND FURTHER TESTING. THE MRI SHOWED A SMALL ISCHEMIC INJURY IN THE LEFT PERIVENTRICULAR WHITE MATTER , ECHOCARDIOGRAM WAS UNREMARKABLE. HE WAS DIAGNOSED WITH LIKELY SMALL VESSEL STROKE AND DISCHARGED HOME ON (B)(6) 2019 WITH NEUROLOGY FOLLOW UP. RECEIPT OF THE ADJUDICATION FORM DEEMED THE EVENT NOT VALVE RELATED.

  Patient problems: Ischemia Stroke

  MAUDE report 18592498 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT IS SUBJECT #040 IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2013 WITH A PREFABRICATED AAP DEVICE SN # (B)(6). ON 3MAR2013 (55 DAYS POST IMPLANT) WHILE HE WAS IN THE HOSPITAL RECOVERING FROM REPAIR OF A PERIAORTIC LEAK WITH A LARGE PSEUDOANEURYSM HE NOTED HIS LEFT PUPIL WAS DILATED. A CT OF THE HEAD WAS PERFORMED AND SHOWED SMALL RIGHT FRONTAL INTRAPARENCHYMAL HEMORRHAGE AND A STABLE BUT SLIGHTLY ENLARGED LEFT TENTORIAL SUBDURAL HEMATOMA. PATIENT WAS DIAGNOSED WITH A RIGHT FRONTAL LOBE IPH FROM SEPTIC EMBOLUS ACCORDING TO REPORTING FROM THE SITE ON THE DIGITAL CRF. PT WAS DISCHARGED HOME ON (B)(6) 2013 TO FOLLOW UP WITH CARDIOLOGY, INFECTIOUS DISEASE AND NEUROLOGY.

  Patient problems: Hematoma

  MAUDE report 18592434 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 19JAN2024 FROM ARTIVION CLINICAL PROJECT MANAGER, E.T., PATIENT IS SUBJECT #040 IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6)2013 WITH A PREFABRICATED AAP DEVICE SN #(B)(6). ON (B)(6)2014 (607 DAYS POST IMPLANT) PRESENTED TO THE ED WITH COMPLAINTS OF LOSS OF VISION TO THE LEFT EYE. ACCORDING TO THE MEDICAL RECORDS PROVIDED HE HAS AN EXTENSIVE HISTORY OF RECURRENT INFECTIOUS ENDOCARDITIS AND SEVERE THROMBOCYTOPENIA. INR WAS 3.0 ON (B)(6)2014. CT OF THE HEAD WITHOUT CONTRAST WAS NORMAL, EKG SHOWED ATRIAL FIBRILLATION WITH A RATE OF 104 (NEW), ECHOCARDIOGRAM SHOWED NO EVIDENCE OF STENOSIS OR REGURGITATION AND NO THROMBUS IDENTIFIED. CTA OF HEAD AND NECK SHOWED CAROTID OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY IN THE NECK, APPEARANCE UNCHANGED SINCE 2013. PATIENT WAS DISCHARGED HOME ON 10SEP2014 TO FOLLOW UP WITH HIS CARDIOLOGIST, NO CHANGES TO HIS COUMADIN WERE MADE. DIAGNOSIS OF RETINAL ARTERY BRANCH OCCLUSION OF THE LEFT EYE.

  Patient problems: Loss of Vision

  MAUDE report 18592328 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, "PATIENT IS SUBJECT#: (B)(6) IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2011 WITH A SURGEON MADE AAP DEVICE AND ON-X AORTIC VALVE SN#: (B)(6). ON (B)(6) 2019 (2941 DAYS POST IMPLANT) PRESENTED TO THE ED WITH A COMPLAINT OF SUDDEN ONSET OF CONFUSION AND EXPRESSIVE APHASIA. HE WAS ADMITTED FOR OBSERVATION AND A CT WAS COMPLETED, SHOWING NO ACUTE HEMORRHAGE AND A SMALL HYPOATTENUATING FOCUS IN THE LEFT BASAL GANGLIA WHICH IS NEW SINCE PREVIOUS CT BUT IS AGE-INDETERMINATE. INR WAS 2.4 AT TIME OF ADMISSION. PATIENT HAD RESOLUTION OF SYMPTOMS WITHIN A FEW HOURS AND WAS BACK TO BASELINE AT TIME OF DISCHARGE HOME ON (B)(6) 2019. ADMITTING DIAGNOSIS: TRANSIENT EPISODE OF GLOBAL APHASIA."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18591786 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 26SEPT2023, "AAP IRC RECEIVED FOR PATIENT WITH AN EXISTING AAP VALVE." ADDITIONAL INFORMATION RECEIVED: PATIENT HAD ENDOCARDITIS (B)(6) 2022, HE ALSO HAD A BICUSPID VALVE. THEREFORE AVR/ASC. COMPLETED IV ABX. (B)(6) 2022 SWITCHED FROM WARFARIN TO ELIQUIS. (B)(6) 2023 PT PRESENTED WITH ISCHEMIC CVA., ECHO NOTED THROMBUS V ENDOCARDITIS. PT TRANSFERRED TO (B)(6). INTRA-OP DANTER DESCRIBED THROMBUS ON VALVE. CULTURE: NEGATIVE FOR ORGANISMS. FIBROUS TISSUE WITH ADHERENT FIBRIN - CHRONIC AND ACUTE INFLAMMATION. ID FOLLOWING OFF ABX- ALL CULTURES NEGATIVE TO DATE. PATIENT STILL IN POST OP ¿ NOT YET RELEASED AS OF TODAY,(B)(6) 2023."

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 17834152 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IN THE ASCEND STUDY EXPERIENCED AN ISCHEMIC STROKE.

  Patient problems: Ischemia Stroke

  MAUDE report 17574239 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SURGEON HAD FOUR PATIENTS RECENTLY THAT RECEIVED ONXAAPS END UP WITH INFECTIONS. TWO REQUIRED TAKE BACK TO THE OPERATING ROOM FOR WASHOUT DUE TO PERICARDIAL EFFUSIONS/MEDIASTINAL FLUID COLLECTIONS. SWABS WERE TAKEN OF THE MEDIASTINAL FLUID AND DID NOT GROW ANY ORGANISMS. ALL FOUR PATIENTS HAD ELEVATED WBC [WHITE BLOOD CELL] COUNTS. INDIUM NUCLEAR WBC SCAN WERE POSITIVE ON ALL FOUR WITH UPTAKE AROUND THE AORTA. THIS INVESTIGATION IS RELEGATED TO ONE OF THE FOUR PATIENTS WITH DATE OF IMPLANT: (B)(6) 2023.

  Patient problems: Endocarditis; Pericardial Effusion; Unspecified Infection

  MAUDE report 17350575 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SURGEON HAD FOUR PATIENTS RECENTLY THAT RECEIVED ONXAAPS END UP WITH INFECTIONS. TWO REQUIRED TAKE BACK TO THE OPERATING ROOM FOR WASHOUT DUE TO PERICARDIAL EFFUSIONS / MEDIASTINAL FLUID COLLECTIONS. SWABS WERE TAKEN OF THE MEDIASTINAL FLUID AND DID NOT GROW ANY ORGANISMS. ALL FOUR PATIENTS HAD ELEVATED WBC [WHITE BLOOD CELL] COUNTS. INDIUM NUCLEAR WBC SCAN WERE POSITIVE ON ALL FOUR WITH UPTAKE AROUND THE AORTA. THIS INVESTIGATION IS RELEGATED TO ONE OF THE FOUR PATIENTS WITH DATE OF IMPLANT: ON (B)(6) 2023.

  Patient problems: Endocarditis; Pericardial Effusion; Unspecified Infection

  MAUDE report 17350455 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED CARDIAC ARRHYTHMIA ON (B)(6) 2021, 1-DAY FOLLOWING IMPLANT WITH THE DEVICE (IMPLANTED ON (B)(6) 2021).

  Patient problems: Arrhythmia

  MAUDE report 15933930 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED PERICARDIAL EFFUSION AND CARDIAC TAMPONADE, WHICH REQUIRED REOPERATION ON (B)(6) 2022, 7-DAYS FOLLOWING IMPLANT WITH THE DEVICE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 15640760 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED A PSEUDOANEURYSM AND UNDERWENT REOPERATION ON (B)(6), 2022, 16-DAYS FOLLOWING IMPLANT WITH THE DEVICE.

  Patient problems: Pseudoaneurysm

  MAUDE report 15640604 ↗
• InjuryJun 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SUBJECT AAP-098 IN THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, EXPERIENCED TWO ADVERSE EVENTS: ON (B)(6) 2018 1 DAY POST IMPLANT, SUBJECT EXPERIENCED A STROKE (CVA). AT TIME OF EVENT THE SUBJECTS INR WAS 1.8. NO FURTHER DETAILS WERE PROVIDED. ON (B)(6) 2018, THE SUBJECT EXPERIENCED A COMPLETE HEART BLOCK WHICH REQUIRED A PERMANENT PACEMAKER TO BE IMPLANTED. SUBJECT WAS DISCHARGED 3 DAYS LATER.

  Patient problems: Heart Block; Stroke/CVA

  MAUDE report 14822894 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "SUBJECT: (B)(6) ON (B)(6) 2016 124 DAYS POST IMPLANT, SUBJECT EXPERIENCED THROMBOSIS WHICH REQUIRED A CORONARY ANGIOGRAPHY ((B)(6) 2016), REDO STERNOTOMY ((B)(6) 2016) AND ASCENDING AORTIC ARCH REPLACEMENT ((B)(6) 2016). THE IMPLANT WAS ALSO REMOVED ON (B)(6) 2016. AT TIME OF HOSPITALIZATION THE SUBJECTS INR WAS 2.6. THEY WERE DISCHARGED ON (B)(6) 2016. SUBJECT IN THE POST MARKET STUDY: (B)(6)- POST MARKET CLINICAL FOLLOW UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY. PI: [SURGEON]. WHILE ARTIVION REPRESENTATIVE WAS PERFORMING PAPER CRF REVIEW, ADVERSE EVENTS WERE DISCOVERED AS THEY WERE DOCUMENTED IN CRF SUBMITTED FOR STUDY. MEDICAL RECORDS/SOURCE DOCUMENTATION HAS NOT BEEN PROVIDED FOR REVIEW AND WILL NOT LIKELY BE OBTAINED. GIVEN THE RETROSPECTIVE NATURE, THESE EVENTS ARE NOT CURRENT. (STUDY TIMELINE IS 2008-2018) IDENTIFIED EVENTS WERE REPORTED TO FIELD ASSURANCE IN A PER SUBJECT REPORT."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14744808 ↗
• DeathJun 13, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN PERFORMING A PAPER CRF REVIEW OF THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENTS WERE DISCOVERED FOR SUBJECT AAP-064: ON (B)(6) 2014, 12 DAYS POST IMPLANT, SUBJECT EXPERIENCED VT CAUSING THE PATIENT TO WEAR A LIFE VEST. PATIENT WAS DISCHARGED 3 DAYS LATER. ON (B)(6) 2015, SUBJECT EXPERIENCED SUSTAINED MONOMORPHIC VT AND WAS GIVEN ORAL AMIODARONE LOAD AND DISCHARGED ON (B)(6) 2015. AT TIME OF ADMISSION THE PATIENTS INR WAS 3.0. PER NOTATIONS MADE ON CRF, SUBJECT IS KNOWN TO BE DECEASED BUT CAUSE OF DEATH AND DATE OF DEATH ARE UNKNOWN.

  Patient problems: Arrhythmia

  MAUDE report 14674621 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  POST MARKET CLINICAL FOLLOW UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) - SUBJECT ON 17JUL2014 43 DAYS POST IMPLANT, SUBJECT EXPERIENCED VENTRICULAR TACHYCARDIA. SUBJECT WAS STARTED ON AN IV OF AMIODARONE AND WAS DISCHARGED 5 DAYS LATER. ON (B)(6) 2015, SUBJECT EXPERIENCED VENTRICULAR TACHYCARDIA WAS HOSPITALIZED FOR 3 DAYS AND THEN DISCHARGED, NO OTHER DETAILS OF THE EVENT WERE PROVIDED. PRODUCT CODE AND SERIAL NUMBER ARE UNKNOWN. THE VALVE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Arrhythmia; Tachycardia

  MAUDE report 14605341 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PARTICIPANT IN PROACT XA STUDY ASSESSED TO HAVE SUFFERED FROM STROKE AND/OR ARTERIAL OR SYSTEMIC THROMBOEMBOLISM. TREATMENT ARM: APIXABAN MOST RECENT INRS: 1.6 ON (B)(6). PRODUCT CODE AND SERIAL NUMBER UNKNOWN.

  Patient problems: Stroke/CVA; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 14605095 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, "SUBJECT: AAP- 067 ON (B)(6) 2014 1 DAY POST IMPLANT, SUBJECT EXPERIENCED ATRIAL FIB WITH RVR AND WAS STARTED ON AMIODARONE DRIP IV AND THEN WAS CHANGED TO AMIODARONE 400MG TAB. AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY. PI: [SURGEON]. WHILE ARTIVION REPRESENTATIVE WAS PERFORMING PAPER CRF REVIEW, ADVERSE EVENTS WERE DISCOVERED AS THEY WERE DOCUMENTED IN CRF SUBMITTED FOR STUDY. MEDICAL RECORDS/SOURCE DOCUMENTATION HAS NOT BEEN PROVIDED FOR REVIEW AND WILL NOT LIKELY BE OBTAINED. GIVEN THE RETROSPECTIVE NATURE, THESE EVENTS ARE NOT CURRENT. (STUDY TIMELINE IS 2008-2018) IDENTIFIED EVENTS WERE REPORTED TO FIELD ASSURANCE IN A PER SUBJECT REPORT. CRFS THAT WERE PROVIDED ARE ATTACHED TO THIS REPORT."

  Patient problems: Atrial Fibrillation

  MAUDE report 14548128 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED SUBJECT: AAP- 059 ON (B)(6) 2013 11 DAYS PRIOR TO IMPLANT, SUBJECT EXPERIENCED ENDOCARDITIS OF THE ANNULS [ANNULUS]. THERE WERE SEVERAL PROCEDURES PERFORMED BUT ONLY 2 CAN BE IDENTIFIED FROM THE ADVERSE EVENT FORM, REDO STERNOTOMY AND A HEMI ARCH REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED. A REVIEW OF THE AVAILABLE INFORMATION RELAYED THE PATIENT HAD A VALVE IMPLANTED IN 2013 BUT THEN UNDERWENT REDO IN 2014. (THE PRE-OP ECHO CRF DATA INDICATES VEGETATION WAS PRESENT). THE TIMELINE EXTRACTED: (B)(6) 2013- INITIAL REPLACEMENT (B)(6) 2013- AE START DATE PER CRF (CASE REPORT FORM) (B)(6) 2013- PRE-OP ECHO (B)(6) 2014- RE-DO WITH ONX IMPLANT ALL CRFS INDICATE SOME SORT OF VEGETATION ON THE VARIOUS ECHO FINDINGS. IN LIGHT OF THE DATES, I WANT TO SAY THE ENDOCARDITIS WAS PRE-EXISTING. THE INFORMATION PROVIDED IS ALL WE WILL BE ABLE TO GET FROM THE SITE. THIS INVESTIGATION IS RELEGATED TO ONXAAP-25 SERIAL NUMBER: (B)(4). NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Endocarditis

  MAUDE report 14347198 ↗
• DeathNov 6, 2015Insufficient Device Problem Information

  WHILE ENTERING IMPLANT REGISTRATION CARD INFO., ON-X OPERATOR NOTICED THAT PATIENT ADDRESS INFO WAS NOT PRESENT. CALLED THE HOSPITAL TO GET THE INFO. HOSPITAL REPORTED TO USE THE FOLLOWING: THIS ASCENDING AORTIC PROSTHESIS , 25MM, (A VALVED CONDUIT) WAS IMPLANTED ON (B)(6) 2015 BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). IN THE PROCESS OF TRYING TO OBTAIN THE MISSING PATIENT ADDRESS INFO FORM THE SURGEON'S OFFICE IT WAS DISCOVERED THAT THE PATIENT HAD PASSED AWAY. THE HOSPITAL STATED THE FOLLOWING NOTES ABOUT THIS PATIENT: (B)(6) 2015: THE PATIENT REMAINS INTUBATED AND UNRESPONSIVE. (B)(6) 2015: THE PATIENT IS STILL INTUBATED, AWAKE, EYES OPEN AND CLOSE. INTUBATED MEANS PATIENT NOT ABLE TO BREATHE ON HIS OWN. THE PATIENT REMAINED IN THE HOSPITAL UNTIL HIS DEATH. HIS CAUSE OF DEATH WAS READ AS: "INTRACRANIAL HEMORRHAGE". PER THE AATS/STS GUIDELINES, BLEEDING EVENTS SUCH AS THIS ARE DEFINED TO BE VALVE-RELATED, AND THEREFORE REPORTABLE. WE HAVE NOT INFORMATION ON THE PATIENT'S ANTICOAGULATION THERAPY BUT WE ARE COMPELLED TO ASSUME THAT THIS PATIENT WAS ADMINISTERED ANTICOAGULATION THERAPY AND THEREFORE, SUCH A BLEEDING EVENT COULD BE VALVE-RELATED. THERE IS NO OTHER INFORMATION ABOUT

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 5208455 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000037. One submission often covers many models, so check the product and lot details in each record.

• Z-2133-2026 · Feb 1, 2026 · Open, Classified
  On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
• Z-1073-2019 · Jan 17, 2019 · Terminated
  On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native
• Z-2715-2017 · Jun 12, 2015 · Terminated
  On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positio
• Z-3108-2017 · Feb 12, 2014 · Terminated
  On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in th