MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESISWITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number ONXAAP-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Failure (2041)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

According to the initial report received, study patient experienced acute renal failure on (b)(6) 2022, 1-day following implant with the device (implanted on (b)(6) 2022).

Manufacturer Narrative

The manufacturing records for onxaap-21, 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.An onxaap 21 with serial number (b)(6) was implanted on (b)(6) 2022 with a concomitant coronary artery graft bypass (cabg) x1 svg-rca in a 42-year-old female with a past medical history of svt, hypothyroid, hypertension, presumed asthma, congenital bicuspid aortic valve and ascending aortic aneurysm with a previous ascending aortic aneurysm repair in 2005 and an aortic valve replacement with a [non-artivion] 19mm valve in 2014.The subject was enrolled in the study and this event refers to study patient.On (b)(6) 2022 (1 day post implant) the medical notes state ¿stage 2 acute kidney injury likely cpb (cardiopulmonary bypass) related injury (based on casty urine on arrival to icu) plus iv contrast last night, will continue to monitor¿ on (b)(6) 2022 (8 days post implant) the notes state ¿aki (acute kidney injury) stage 3, unstable in setting of cardiogenic shock and cardiac arrest.Likely secondary to atn (acute tubular necrosis)/crs (cytokine release syndrome) in the setting of hypotension intro or postop, compounded by contract received on 9mar.Also now worsened by multiple cardiac arrests.Continue with crrt (continuous renal replacement therapy) with cvvhd (continuous venovenous hemodialysis.¿ the final note at time of discharge on (b)(6) 2022 ¿tunneled line removed on 12may, no dialysis required.Foley remains in place to monitor output.On high dose diuretics to challenge her kidneys.Continued to be followed by nephrology.¿ the adverse event of acute kidney injury is not specified in the ifu, however according to the medical notes the acute kidney injury is presented as a likely complication related to the use of cpb during the procedure and compounded by the cardiac and stroke events that occurred after the implant procedure.The adverse event of acute kidney injury is not specified in the ifu, however according to the medical notes the acute kidney injury is presented as a likely complication related to the use of cpb during the procedure and compounded by the cardiac and stroke events that occurred after the implant procedure.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and 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- formerly cryolife/jotec is accurate or has been confirmed by artivion.References: on-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.Iso 5840-2:2021 (e) cardiovascular implants - cardiac valve prostheses, annex i.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESISWITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15933807
• MDR Text Key: 305002442
• Report Number: 1649833-2022-00062
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001518
• UDI-Public: 851788001518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAAP-21
• Device Catalogue Number: ONXAAP-21
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 99 KG