MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505DA20

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Material Separation (1562)

Patient Problems Host-Tissue Reaction (1297); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has been returned and device analysis is pending.Upon completion of the analysis and investigation, a supplemental report will be sent.Conclusion: without completed product analysis and investigation, a 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 5 years and 4 months post implant of this 20mm aortic mechanical valve, it was explanted and replaced with a 27mm full-root aortic bioprosthetic valve.The mechanical valve was replaced due to severe perivalvular leak (pvl), with probable valvular dehiscence into the right ventricle.It was reported that the valve had degenerative calcific aortic stenosis, with a max gradient of 69mmhg, and a mean gradient of 41mmhg.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed two pieces of native host tissue were returned with the valve.Two pledgets with blue monofilament sutures remained attached to the remnant host pieces.Damage to the sewing ring was observed, which most likely occurred during the explant process.Blue multifilament suture remained attached to the sewing ring, adjacent to one of the markers.Both leaflets were in the closed position and were intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.Remnants of glistening pannus were attached the sewing ring on the inflow and outflow.An unknown amount of pannus appears to have been removed during explant.Radiography revealed calcification on the sewing ring and remnant host pieces.Using a blue actuator to test leaflet movement, the leaflets moved normally.Due to the pannus, the carbon subassembly could not be rotated in the sewing ring.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There is no evidence to establish a relationship between the device and the paravalvular leak (pvl).The pvl was most likely caused by the valvular dehiscence.Dehiscence can be caused by a variety of factors, including implant condition/technique, patient anatomy, or presence of pre-existing patient conditions.Per the analysis, there is no evidence to establish a relationship between the device and the dehiscence.Reduced performance of the valve is attributed to calcification and host tissue overgrowth.These findings are generally considered a patient-related condition.Coding updated 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.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9297036
• MDR Text Key: 165632926
• Report Number: 3008592544-2019-00058
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2016
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR