MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Fever (1858); Pseudoaneurysm (2605); Heart Block (4444)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Medtronic received information via literature regarding a 36-year-old male patient with atopic dermatitis who developed infective endocarditis (ie) due to staphylococcus aureus (s.Aureus) in 2017 and 2020.The patient underwent implant of ats open pivot aortic and mitral mechanical valves, in 2017 and 2020 respectively (unique device identifier numbers not provided).Post-operatively, the patient developed complete atrioventricular (av) block, requiring permanent pacemaker implantation (ppmi).In 2021, the patient presented to the hospital with a persistent high fever.Transthoracic echocardiography (tte) noted ¿a trembling aortic prosthetic valve,¿ computed tomography (ct) detected aortic pseudoaneurysms and blood cultures were again positive for s.Aureus, leading to a new ie diagnosis.The patient underwent surgery to remove the pacemaker leads and replace the mechanical valves with new open pivot aortic/mitral valves (unique device identifier numbers not provided).Intra-operatively, the aortic annulus was noted to be infected with pseudoaneurysms and pledgets sown into the site from the prior surgeries were also infected.The patient was placed on antibiotics, which were continued upon hospital discharge.Post-operative tte and one-year follow-up revealed no issues.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: yajima s.; et al.A novel patch-sparing technique for reconstruction of the aortomitral curtain.Eur j cardiothorac surg 2022; doi:10.1093/ejcts/ezac405.Pmid: (b)(6).Advance access publication 29 july 2022.Medtronic products referenced: ats open pivot (pma# p990046, product code: lwq).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15974648
• MDR Text Key: 305414629
• Report Number: 3008592544-2022-00081
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• 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
• Treatment: UNKNOWN IPG.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Race: Asian