MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW VALVE; TISSUE HEART VALVE

Model Number TBD

Device Problems Degraded (1153); Positioning Problem (3009)

Patient Problem Aortic Regurgitation (1716)

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

Obtained information from a paper entitled: "aortic root morphology can cause early bioprosthetic valve failure of externally mounted pericardial bioprosthesis." source: general thoracic and cardiovascular surgery.Https://doi.Org/10.1007/s11748-020-01402-6.A (b)(6)-year-old woman with a narrow aortic root had undergone aortic valve replacement with a 19-mm mitroflow valve.Aortic annular enlargement with manouguian¿s technique was performed, and the bioprosthesis had been implanted on the tilt in a supra-annular position.Four years after the implantation, echocardiography showed a significant de novo aortic regurgitation, which had not been detected 1 year earlier.In the reoperation, the left coronary leaflet of the bioprosthesis had attached and fused to the wall of the sinus of valsalva, causing deformation of the valve leaflet and a commissural gap between the left and right coronary leaflets, which appeared to have caused the de novo aortic regurgitation.We assessed the cause of early valve deterioration by focusing on the morphology of the aortic root.Redo avr was performed after median resternotomy.After explantation of the mitroflow valve, the 19-mm inspiris resilia (edwards lifesciences, (b)(4) us) valve, a stented bovine pericardial valve, was implanted in the same position.Peri- and post-operative courses were uneventful.The patient currently visits our hospital as an outpatient, and the follow-up echocardiography conducted 1 year post-operatively showed normal valve function.

Manufacturer Narrative

A 73-year-old woman with a very small aortic annulus had undergone avr with a 19-mm mitroflow valve for severe aortic stenosis 4 years ago.In the initial avr, an intraoperative measurement of the aortic annular diameter showed that it was significantly smaller than 19 mm, necessitating aortic annular enlargement to implant a bioprosthesis.Manouguian¿s technique, which enables implantation of a two size-larger bioprosthesis, was performed along with reconstruction of the aortic annular defect using an autologous pericardium, and the 19-mm mitroflow valve was implanted in a supra-annular position.Sutures were placed around the annulus at the native part and from outside the patch into the aorta at the augmented part.The suture line was lifted at the augmented area and the mitroflow valve had been implanted on the tilt, with the indexed effective orifice area (eoa) at an implantation of 0.71 cm2 /m2.The patient experienced no adverse events for 4 years, but suddenly presented with dyspnea.Echocardiography showed a more-than-moderate, transvalvular aortic regurgitation (ar), which had not been detected 1 year earlier.Right heart catheterization showed low cardiac output of 1.55 l/min/m2, and the peak value of b-type natriuretic peptide was 281.1 pg/ml.There were no episodes of infectious endocarditis during the follow-up period.Preoperative computed tomography (ct) showed that the stent posts on each side of the left coronary leaflet of the bioprosthesis were attached to the aortic wall and another one maintained a distance from the aortic wall, and that the left coronary leaflet did not coapt to the facing leaflets at diastole.The site assessed that the significant de novo ar resulted from valve deterioration, requiring reoperation.Redo avr was performed after median resternotomy.Intraoperatively, the left coronary leaflet of the bioprosthesis had attached and fused to the wall of the corresponding sinus of valsalva (sov), resulting in the deformation of the valve leaflet and a resultant commissural gap between the left and right coronary leaflets as shown by the preoperative ct, which appeared to be the mechanism of the de novo ar.The excised valve leaflets did not exhibit calcification, except at the contact point to the wall of the sov, sclerotic changes, or leaflet tear, suggesting that ar did not result from an early degeneration of the mitroflow valve leaflet.After explantation of the mitroflow valve, the 19-mm inspiris resilia (edwards lifesciences, irvine, ca, us) valve, a stented bovine pericardial valve, was implanted in the same position.Peri- and post-operative courses were uneventful.The patient currently visits our hospital as an outpatient, and the follow-up echocardiography conducted 1 year post-operatively showed normal valve function.The manufacturer received the following information from the physician.This event is not a functional problem with the mitroflow.Because there was no functional issue with the device no further information will be provided.The device has already been discarded at the hospital.Based on the information provided in the paper and the information from the physician the event was not attributed to a functional issue with the mitroflow device.The device was malpositioned initially resulting in aortic regurgitation and consequent valve replacement.The site findings did not show calcification or svd.Based on this information no further investigations will be performed and the event root cause is deemed to be cause traced to user : unintended use error caused or contributed to event: malpositioning.

Event Description

A 73-year-old woman with a very small aortic annulus had undergone avr with a 19-mm mitroflow valve for severe aortic stenosis 4 years ago.In the initial avr, an intraoperative measurement of the aortic annular diameter showed that it was significantly smaller than 19 mm, necessitating aortic annular enlargement to implant a bioprosthesis.Manouguian¿s technique, which enables implantation of a two size-larger bioprosthesis, was performed along with reconstruction of the aortic annular defect using an autologous pericardium, and the 19-mm mitroflow valve was implanted in a supra-annular position.Sutures were placed around the annulus at the native part and from outside the patch into the aorta at the augmented part.The suture line was lifted at the augmented area and the mitroflow valve had been implanted on the tilt, with the indexed effective orifice area (eoa) at an implantation of 0.71 cm2 /m2.The patient experienced no adverse events for 4 years, but suddenly presented with dyspnea.Echocardiography showed a more-than-moderate, transvalvular aortic regurgitation (ar), which had not been detected 1 year earlier.Right heart catheterization showed low cardiac output of 1.55 l/min/m2, and the peak value of b-type natriuretic peptide was 281.1 pg/ml.There were no episodes of infectious endocarditis during the follow-up period.Preoperative computed tomography (ct) showed that the stent posts on each side of the left coronary leaflet of the bioprosthesis were attached to the aortic wall and another one maintained a distance from the aortic wall, and that the left coronary leaflet did not coapt to the facing leaflets at diastole.The site assessed that the significant de novo ar resulted from valve deterioration, requiring reoperation.Redo avr was performed after median resternotomy.Intraoperatively, the left coronary leaflet of the bioprosthesis had attached and fused to the wall of the corresponding sinus of valsalva (sov), resulting in the deformation of the valve leaflet and a resultant commissural gap between the left and right coronary leaflets as shown by the preoperative ct, which appeared to be the mechanism of the de novo ar.The excised valve leaflets did not exhibit calcification, except at the contact point to the wall of the sov, sclerotic changes, or leaflet tear, suggesting that ar did not result from an early degeneration of the mitroflow valve leaflet.After explantation of the mitroflow valve, the 19-mm inspiris resilia (edwards lifesciences, irvine, ca, us) valve, a stented bovine pericardial valve, was implanted in the same position.Peri- and post-operative courses were uneventful.The patient currently visits our hospital as an outpatient, and the follow-up echocardiography conducted 1 year post-operatively showed normal valve function.The manufacturer received the following information from the physician.This event is not a functional problem with the mitroflow.Because there was no functional issue with the device no further information will be provided.The device has already been discarded at the hospital.

• Brand Name: MITROFLOW VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10383035
• MDR Text Key: 203487812
• Report Number: 3004478276-2020-00172
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR