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

Model Number 995

Device Problems Calcified (1077); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Calcium Deposits/Calcification (1758); Fistula (1862); High Blood Pressure/ Hypertension (1908); Rupture (2208); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

Citation: sharew et al.Transcatheter aortic valve replacement in congenital heart disease.Jacc: case reports.Volume 29, issue 4, 21 february 2024.Doi.Org/10.1016/j.Jaccas.2023.102199.Available online january 6, 2024.Earliest date of publication used for date of event.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.

Event Description

Literature was reviewed regarding a 49-year-old-male patient with shone syndrome, bicuspid aortic valve, and aortic coarctation. his medical history includes five previous open-heart surgeries: atrio-ventricular (av) repair, aortic coarctation repair with end-to-end anastomosis, redo av repair, aortic and pulmonary homograft placement, and redo aortic root with implant of a medtronic freestyle 25 mm bioprosthesis and pulmonary homograft replacement. next, he underwent implant of a pulmonary artery covered stent and transcatheter pulmonary valve replacement to address a fistulous connection between his ascending aorta and pulmonary artery causing severe pulmonary arterial hypertension, with subsequent resolution of pulmonary hypertension.  two years later, the patient presented with abrupt-onset dyspnea and volume overload due to severe aortic regurgitation (ar) of a heavily calcified homograft with a ruptured cusp. a non-medtronic balloon-expandable bovine pericardium valve was successfully implanted via the transfemoral approach. postoperatively, the av peak gradients were 10 mmhg with no signs of ar.  no further information was provided pertaining to medtronic products.

• 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: 18717294
• MDR Text Key: 335525480
• Report Number: 2025587-2024-00930
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 01/24/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male