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

Model Number 505DA22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Vasodilatation (2127)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Implant date is month/year valid 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 approximately 18 years and 11 months post implant of this 22mm aortic mechanical valve, the patient presented with annuloaortic ectasia (aae).As part of the bio-bentall surgical approach used to treat the aae, the mechanical aortic valve was replaced with a bioprosthetic valve.It was reported that this was not a product defect, and there is no information to suggest that the device caused or contributed to the aae.No additional adverse patient effects were reported.

Manufacturer Narrative

D4: serial number added d6: implant date added d10: return date added h6: coding updated 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 examination showed that both leaflets were in the closed position with no evidence of damage such as cracks or surface anomalies.The sewing ring appeared damaged likely from the explant process.Both inflow and outflow valve hinge mechanism were intact, and the inflow and outflow orifices were intact with no evidence of damage.Remnants of glistening pannus were attached along the sewing ring on the inflow and outflow.An unknown amount of pannus appears to have been removed during explant.When tested with an actuator, the leaflets appeared to move without difficulty.Due to the pannus, the carbon subassembly could not be rotated in the sewing ring.Conclusion: it was stated that there was no product defect, and the device did not cause or contribute to the reported annuloaortic ectasia.A relationship between the device and the annuloaortic ectasia could not be established.D4: serial # and udi # added d10: device evaluation information added h3: device evaluation information added h6: coding updated 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: 9566771
• MDR Text Key: 174284151
• Report Number: 3008592544-2020-00003
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DA22
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR