ONX ASCENDING AORTIC 23
Report
- Report Number
- 1649833-2022-00021
- Event Type
- Injury
- Date Received
- June 3, 2022
- Date of Event
- October 3, 2013
- Report Date
- August 5, 2022
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- UDI-DI
- 00851788001525
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ACCORDING TO THE INITIAL REPORT, SUBJECT IN THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY EXPERIENCED THE FOLLOWING EVENT: ON (B)(6) 2013 99 DAYS POST IMPLANT, SUBJECT EXPERIENCED A 10 DAY HOSPITALIZATION FOR A NON-ST-ELEVATION MYOCARDIAL INFARCTION. AT THE TIME OF THE HOSPITALIZATION THE SUBJECTS INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.5. SUBJECT RECEIVED A HEART CATH (CATHETERIZATION) AND WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE SUBJECT HAD REOPERATION; CORONARY ARTERY BYPASS GRAFT SURGERY. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED.
ACCORDING TO THE INITIAL REPORT, SUBJECT IN THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY EXPERIENCED THE FOLLOWING EVENT: ON (B)(6) 2013 99 DAYS POST IMPLANT, SUBJECT EXPERIENCED A 10 DAY HOSPITALIZATION FOR A NON-ST-ELEVATION MYOCARDIAL INFARCTION. AT THE TIME OF THE HOSPITALIZATION THE SUBJECTS INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.5. SUBJECT RECEIVED A HEART CATH (CATHETERIZATION) AND WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE SUBJECT HAD REOPERATION; CORONARY ARTERY BYPASS GRAFT SURGERY. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1801332 | ONX ASCENDING AORTIC 23 | HEART-VALVE, MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXAAP-23 | 00851788001525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male | Hospitalization| L |