MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261); Respiratory Insufficiency (4462)

Event Date 08/03/2023

Event Type  Death  

Event Description

Literature was reviewed regarding a patient who was treated for fungal endocarditis of a pulmonary homograft.Previously, the patient had a medtronic contegra valved conduit implanted in the right ventricular outflow tract (rvot) that was subsequently replaced with a homograft due to endocarditis (staphylococcus aureus) at an unspecified time after implant.It was stated that the previous cardiac operations had been conducted at external hospitals.Sometime later, the patient was admitted to the authors facility and underwent an urgent operation due to severe pulmonary homograft obstruction and possible septic embolization.During the surgery, the homograft was removed and replaced with a medtronic freestyle bioprosthesis.Microbiologic analysis revealed candida albicans in the explanted homograft tissue.Perioperative antifungal medication was administered (caspofungin and fluconazole).The post-operative course was complicated by the onset acute of kidney injury requiring continuous renal replacement therapy, and respiratory insufficiency needing tracheotomy.On post-operative day 46, the patient was discharged.Three months later, the patient was readmitted due to out-of-hospital cardiac arrest.On admission, an electrolyte imbalance was diagnosed.Subarachnoid bleeding and progressive multi-organ failure led to the patient¿s death.The authors wrote, ¿during the short hospital stay, no signs of infection relapse in echocardiography could be recorded.¿ no further information pertaining to medtronic products was noted.

Manufacturer Narrative

Citation: peivandi a, dell'aquila a, kaleschke g, rukosujew a.Surgical considerations for treatment of fungal homograft endocarditis in re-re-re-re-do.Thorac cardiovasc surg rep.2023;12(1):e48-e50.Published 2023 aug 3.Doi:10.1055/s-0043-1770983.Earliest date of publication used for date of event and date of death.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: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17641955
• MDR Text Key: 322170234
• Report Number: 2025587-2023-03555
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 29 YR
• Patient Sex: Female