MAUDE Adverse Event Report: HEART VALVES SANTA ANA HALL EASY FIT; HEART-VALVE, MECHANICAL

Model Number A7700-25

Device Problems Calcified (1077); Mechanical Problem (1384); Incomplete Coaptation (2507)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Death (1802); Thrombus (2101)

Event Date 04/30/2019

Event Type  Death  

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 26 years 6 months post implant of this 25mm aortic mechanical valve, the patient passed away.During the autopsy, the pathologist noticed a "build up" in the form of a clot between the leaflets which caused an obstruction which would not allow the leaflets to completely close and they remained open.The cause of death is reported to be listed as entrapment of the leaflet due to organized thrombus.

Manufacturer Narrative

Which was inadvertently not added during initial medwatch.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Updated coding product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the disc of the valve to be intact with no visible evidence of damage.Pannus growth was observed on the inflow aspect encroaching onto the inflow orifice area.From the outflow view, a layer of thrombotic host tissue and pannus growth was observed on the inflow rim of the valve housing unit.Pannus on the orifice area limited the mobility of the disc.From the inflow view, pannus growth was observed on the pivots of the valve housing.There was no evidence of damage to the valve housing.An unknown amount of pannus appeared to have been removed on the inflow and outflow tract during explant.Radiography revealed traces of calcification on the sewing ring.Conclusion: the investigation for this case is ongoing.Upon completion of the investigation a supplemental report will be sent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: based on the received information the leaflet motion was caused by thrombus formation.There did not appear to be any evidence of damage such as crack and / or gouges on the valve housing where host tissue has not extended to.Traces of pannus was observed on the outflow rim, some of which encroached onto the orifice area.Regurgitation was most likely caused by the reported leaflet motion issue.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Updated date of death- physician thought it was this date, but is unconfirmed.Updated evel code conclusion.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

Medtronic received additional information that the patients international normalized ratio (inr) 3 months before death was 2.7, 3 mo nths before death was 2.9 and in the emergency room on the date of death was 2.4.The patient was anticoagulated with coumadin and treated with lisinopril for hypertension.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

Medtronic received additional information that the patients international normalized ratio (inr) 3 months before death was 2.7, 2 mo nths before death was 2.9 and in the emergency room on the date of death was 2.4.The patient was anticoagulated with coumadin and treated with lisinopril for hypertension.Medtronic received additional information that there was also regurgitation present of unknown severity.The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.Added patient code and evaluation code result to field h6, and corrected description.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: HALL EASY FIT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8632436
• MDR Text Key: 145787568
• Report Number: 2025587-2019-01668
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700-25
• Device Catalogue Number: A7700-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 81