MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC ULTRA PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U2J21

Device Problems Calcified (1077); Material Separation (1562); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Corneal Pannus (1447); Aneurysm (1708); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Thrombosis (2100); Cusp Tear (2656)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years and 5 months post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with a non-medtronic device due to stenosis and an ascending aortic aneurysm.It was reported the stenosis occurred due to calcification and pannus on the valve leaflets.No additional adverse patient effects were reported. .

Manufacturer Narrative

Corrected coding in h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed that the valve sewing ring was partially removed during explant.There were remnants of green and white multifilament sutures attached the sewing ring adjacent to the rc outflow rail and the valve was slightly distorted.All leaflets were twisted and in the closed position with a gap in the left (lc) and right (rc) coaptive ridges which resulted in a crowded appearance.All leaflets were slightly stiff but flexible except where host tissue extend on the inflow and outflow.A tear was noted on the right cusp (rc) free margin near the right non-coronary commissure appeared to be due to contact with the superior coaptive junction.A tear on the non-coronary (nc) free margin appeared to be due to contact with the non-coronary (nc) outflow rail.There was thrombotic host tissue on left cusp (lc) margin of attachment.Tissue deterioration was found on the superior coaptive junction of the right non-coronary and left coronary commissures.There was a start of a commissure dehiscence on the left right commissure and the separation of the aortic wall layers can be observed.Thick pannus lined the inflow base stitching encroaching up to 5 mm on the non-coronary (nc) cusp, 5 mm on the right cusp (rc) and 6 mm on the left cusp (lc) and into all inferior coaptive areas.Remnants of pannus were found on the outflow diameter of the sewing ring.An unknown amount of pannus appeared to have been removed from the inflow and outflow during explant.Radiography revealed calcification near the left non-coronary commissure.Conclusion: the valve appeared distorted (oval shaped).The analysis results of the device showed commissures dehiscence, the dehiscence may due to calcification.The pannus overgrowth on the inflow extended several millimeters out onto the left cusp which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility could have caused the valve stenosis.Pannus overgrowth and calcification have been an inherent risk of surgical valve replacement and are addressed in the current risk management file.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Added device serial number d4.Added unique identifier (udi): d4.Updated patient and device code to field h6.Updated evaluation code method to field h6.Updated evaluation code results to field h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 ULTRA PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8491385
• MDR Text Key: 141192081
• Report Number: 2025587-2019-01145
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2012
• Device Model Number: 305U2J21
• Device Catalogue Number: 305U2J21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 67