MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from this patient's physician that approximately three years, six months post-implant of this bioprosthetic aortic valve, transesophageal echocardiogram (tee) found "[p]rosthetic valve dysfunction with prosthetic valve stenosis with a 9 mmhg mean aortic outflow gradient and a calculated aortic valve area of 0.79 cm2.There is also moderate prosthetic valvular insufficiency." three years, seven months post implant of this device, this 23 mm valve was explanted and replaced with a 22 mm mechanical valve due to critical aortic stenosis.The patient presented symptomatically, and the physician reported that upon visualizing the valve in-situ, the valve was "extremely well incorporated.With no evidence whatsoever of perivalvular leak.The three leaflets were surprisingly thickened with inflammatory tissue and rendered nearly immobile.There was a possibility of some sense of regurgitation based on some mild retraction of each of the leaflets." no other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve appeared distorted and oval shaped with the stent posts deflected.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and/or outflow.Tears on the tunica of the non-coronary and left cusps along the inflow margin of attachment appeared to have occurred during explant.All commissures appeared intact.Traces of pannus were observed along the inflow of the sewing ring.Pannus on the outflow was observed on the outflow rails of the right and non-coronary cusps, extending to all three stent posts, to the tops of non-coronary left and left right commissures.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Tan thrombotic appearing host tissue filled and stiffened all cusps on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: a review of the device history record (dhr) was performed for this valve.There were no correlations / issues identified in regard to manufacturing that could be related to this event.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Distortion of the annular ring can restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve causing the stenosis and regurgitation.An unknown amount of pannus appeared to be removed on the inflow and outflow during explant.The pannus overgrowth on the inflow would have further impaired the leaflet mobility leading to stenosis.Immobile leaflets caused by thrombus are known risk and are addressed in the current risk management file.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6177422
• MDR Text Key: 62456138
• Report Number: 2025587-2016-02029
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001732
• UDI-Public: 00643169001732
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 305C
• Device Catalogue Number: 305C223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; 05/10/2017
• Supplement Dates FDA Received: 05/12/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 91