MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING AND EXTENDED HOLDER - 21MM; MECHANICAL HEART VALVE

Model Number	ONXANE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/31/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The on-x 614 heart valve design fmea 940816 01 rev s thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and instruction for use (ifu).Death following cardiac surgery is a known potential complication occuring with the use of prosthetic valves and is not unique to the on-x valve.Without return of the valve, a specific risk cannot be identified.Review of the operative notes does not reveal an allegation of deficiency or a causative correlation to the on-x valve.
Event or Problem Description
Implant recovery card (irc) received indicates that patient underwent double valve surgery on (b)(6) 2016 receiving onxane-21 and onxm-25 indicated for severe aortic insufficiency and severe mitral regurgitation.Procedure performed was "transesophageal echocardiogram [tee], mitral valve replacement, chordal sparing (25 mm on-x mechanical valve), aortic valve replacement (21 mm on-x mechanical valve), extensive pericardial adhesiolysis secondary to extensive pericarditis." additional information received indicated that patient died on (b)(6) 2016.A preliminary autopsy report indicates the following: provisional anatomic diagnoses: cardiovascular system: status post (b)(6) 2016 aortic valve & rnltral valve replacement surgery; both mitral and aortic on-x prosthetic heart valves appear properly positioned and intact; small epicardlal abscess (1 cm) ad]acent to prosthetic mltral valve b, heart with cardlomegaly (569 g); left ventricular hypertrophy; focal scarring of myometrlum suggestive of remote infarct; no acute infarction seen; flbrlnous perlcarditis; calcfflc atherosclerosis of coronary arteries.Pulmonary system: congested appears to lungs ,bilaterally (each lung 720 g); no evidence of acute infarct or pulmonary emboli.A definitive cause of death was not indicated.This report is relegated to the onxane-21 valve.

• Brand Name: ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING AND EXTENDED HOLDER - 21MM
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• MDR Report Key: 5995430
• Report Number: 1649833-2016-00051
• Device Sequence Number: 16297942
• Product Code: LWQ
• UDI-Device Identifier: 00851788001655
• UDI-Public: 00851788001655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 45 YR