MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXACE-27/29

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

Patient Problems Wound Dehiscence (1154); Insufficiency, Valvular (1926)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, "onxace 27/29 (b)(4) was implanted on (b)(6) 2017 and explanted (b)(6) 2019.Additional information received from operative notes for the explant surgery.Preoperative diagnosis: prosthetic valve insufficiency.Postoperative diagnosis: prosthetic valve insufficiency.Procedure performed: third time re-operative sternotomy and aortic valve replacement with 29 millimeter on-x mechanical valve.Open femoral exposure.Ventricular pacing wire.Central venous and radial arterial in placement.Transesophageal echocardiogram.Indication: this (b)(6) gentleman has had aortic valve replacement on two occasions.He presented with some shortness of breath and was worked up, which included an echocardiogram who showed some dehiscence of the aortic valve prosthesis.The risks and benefits of the procedure were discussed with him including the risk of bleeding, infection, stroke, heart attack, and death.He agrees and wants to proceed.Operation: after informed consent, the patient was transported to the operative suite and placed into the supine position.The patient was anesthetized.Arterial and central venous catheters were placed.The patient was positioned and prepped and draped in a standard fashion.Next, the groins were opened to expose the femoral artery and vein.The left common femoral artery and vein were cannulated for cardiopulmonary bypass.The right sided femoral vein was found to be sclerotic.Next, cardiopulmonary bypass was established for 114 minutes.The chest was entered via the previous median sternotomy incision.Adhesions were dissected, freeing up most of the heart on the right side and the aorta.The aorta was cross clamped for so minutes with 750 milliliters of cold blood del nido cardioplegia administered antegrade.Additional 250 milliliters of direct perfusion was administered as well.Next, the aorta was opened.The aortic valve was found to be dehisced mostly except for the anterior part of the valve.The valve was easily removed.The valve was sent for cultures and the annulus was debrided.There was no annular abscess present, but i was suspicious for some infection on and around the valve.Next, the annulus sized to a 29 millimeter on-x mechanical valve.Annular sutures were placed and then passed through the valve sewing ring.The valve was seated, the sutures tied, and the aorta closed with 4-0 prolene in a running fashion.Next, the patient was placed into the head down position.The aortic root was vented, the patient ventilated, and the aortic cross clamp was removed.The heart was paced and weaned from bypass without difficulty.The groin was decannulated.Cannulation sites were oversewn, and protamine was administered.Next, pericardial and mediastinal drains were placed.Ventricular pacing wire was placed.Transesophageal echocardiogram showed good placement of the aortic valve prosthesis with no perivalvular leak and no residual intracardiac air.Next, the pericardium was left open and the sternum closed with interrupted cables.The wound was closed in layers.Sterile dressings were applied.The patient was transported to recovery, having tolerated the procedure well.Culture report came back negative for all tests.

Manufacturer Narrative

The manufacturing records for the onxace-27/29 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.A review of the available information was performed.Onxace-27/29 sn (b)(6) was implanted in the aortic position of a 45-year-old male patient on (b)(6) 2017 to replace a "bovine pericardia! valve" implanted two years prior which had begun to demonstrate stenosis.Upon examination, the bioprosthetic valve also exhibited signs of infection, i.E.Endocarditis, resulting in annular tissue degradation which contributed to dehiscence (separation of valve from annulus).Onxace-27/29 sn (b)(6) was explanted on (b)(6) 2019 (2 years 34 days) and replaced by onxace-27/29 sn (b)(6) due to valve insufficiency, namely paravalvular leak, as a consequence of recurrent dehiscence; the on-x valve was attached only by a small portion of the anterior annulus.Tissue cultures did not show active endocarditis this time, however.The explanted valve was not returned to the manufacturer for examination, but manufacturing history records indicate nothing out of the ordinary.The valve met all manufacturing quality checks.The evidence strongly suggests the deterioration of the annular tissue as a consequence of infection that compromised the attachment of both the bioprosthesis and the first on-x mechanical valve.This dehiscence resulted in paravalvular leaking and its consequent valvular insufficiency.Endocarditis and paravalvular leaks are recognized potential complications of prosthetic valve replacement as are the possibilities of subsequent reoperation and explantation [ifu].For rigid heart valve substitutes, major paravalvular leaks occur at a rate of 0.6 %/pt-yr while endocarditis occurs at a rate of 1.2 %/pt-yr [iso 5840].This is a case of annular tissue deterioration due to infection resulting in paravalvular leakage and consequent valvular insufficiency.The functional qualities of the on-x valve were not otherwise compromised, and the valve operated according to design.No further action required at this time.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

Date of procedure: (b)(6) 2019.Preoperative diagnosis: prosthetic valve insufficiency.Postoperative diagnosis: prosthetic valve insufficiency.Procedure performed: l.Third time re-operative sternotomy and aortic valve replacement with 29 millimeter on-x mechanical valve.2.Open femoral exposure.3.Ventricular pacing wire.4.Central venous and radial arterial in placement.5.Transesophageal echocardiogram.Indication: this 47-year-old gentleman has had aortic valve replacement on two occasions.He presented with some shortness of breath and was worked up, which included an echocardiogram who showed some dehiscence of the aortic valve prosthesis.The risks and benefits of the procedure were discussed with him including the risk of bleeding, infection, stroke, heart attack, and death.He agrees and wants to proceed.Operation: after informed consent, the patient was transported to the operative suite and placed into the supine position.The patient was anesthetized.Arterial and central venous catheters were placed.The patient was positioned and prepped and draped in a standard fashion.Next, the groins were opened to expose the femoral artery and vein.The left common femoral artery and vein were cannulated for cardiopulmonary bypass.The right sided femoral vein was found to be sclerotic.Next, cardiopulmonary bypass was established for 114 minutes.The chest was entered via the previous median sternotomy incision.Adhesions were dissected, freeing up most of the heart on the right side and the aorta.The aorta was cross clamped for so minutes with 750 milliliters of cold blood del nido cardioplegia administered antegrade.Additional 250 milliliters of direct perfusion was administered as well.Next, the aorta was opened.The aortic valve was found to be dehisced mostly except for the anterior part of the valve.The valve was easily removed.The valve was sent for cultures and the annulus was debrided.There was no annular abscess present, but i was suspicious for some infection on and around the valve.Next, the annulus sized to a 29 millimeter on-x mechanical valve.Annular sutures were placed and then passed through the valve sewing ring.The valve was seated, the sutures tied, and the aorta closed with 4-0 prolene in a running fashion.Next, the patient was placed into the head down position.The aortic root was vented, the patient ventilated, and the aortic cross clamp was removed.The heart was paced and weaned from bypass without difficulty.The groin was decannulated.Cannulation sites were oversewn, and protamine was administered.Next, pericardial and mediastinal drains were placed.Ventricular pacing wire was placed.Transesophageal echocardiogram showed good placement of the aortic valve prosthesis with no perivalvular leak and no residual intracardiac air.Next, the pericardium was left open and the sternum closed with interrupted cables.The wound was closed in layers.Sterile dressings were applied.The patient was transported to recovery, having tolerated the procedure well.Culture report came back negative for all tests.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8675356
• MDR Text Key: 147231715
• Report Number: 1649833-2019-00035
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2022
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR