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

Model Number 995

Device Problems Perivalvular Leak (1457); Central Regurgitation (4068)

Patient Problems Pulmonary Valve Stenosis (2024); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/10/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding a 61-year-old male patient who 24 years prior underwent implant of a medtronic freestyle aortic root replacement and 14 years prior underwent pulmonary valve replacement.  more recently the patient presented with acute chest pain.  transthoracic echocardiogram (tte) showed mild paravalvular leak and moderate-severe pulmonary stenosis, and transesophageal echocardiogram (tee) revealed severe aortic regurgitation.  as the patient was considered high risk for a repeat sternotomy, the heart team decided to perform first a transcatheter aortic valve replacement and one month later a transcatheter pulmonary valve replacement.  the patient underwent successful valve-in-valve tavr with implant of a stentless non-medtronic bioprosthetic valve, followed by a successful transcatheter pulmonary valve replacement procedure with implant of a non-medtronic bioprosthetic valve.  at one month follow-up with patient was noted as asymptomatic with well-seated non-regurgitant bioprosthetic valves in both aortic and pulmonary positions.No further information pertaining to medtronic products was noted.

Manufacturer Narrative

Citation: gustafson et al.Sequential transcatheter aortic and pulmonic valve replacement in bioprosthetic valve dysfunction: a case report.Eur heart j case rep.2023 apr 10;7(4):ytad170.Doi: 10.1093/ehjcr/ytad170.Ecollection 2023 apr.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.

• 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: 17954496
• MDR Text Key: 325898673
• Report Number: 2025587-2023-04186
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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: 09/20/2023
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male