MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number A7700

Device Problems Degraded (1153); Perivalvular Leak (1457)

Patient Problems Inflammation (1932); Valvular Insufficiency/ Regurgitation (4449)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Citation: saucedo-orozco h.; et al.Bioprosthesis in aortic valve replacement: long-term inflammatory response and functionality.Open heart, 2022 aug;9(2):e002065.Doi: 10.1136/openhrt-2022-002065.Pmid: 35926961.Earliest date of publication used for date of event.Medtronic products referenced: hall mechanical aortic (pma# p790018, product code: lwq); ats 3f aortic valve (pma# p060025, product code: lwr).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.

Event Description

Medtronic received information via literature regarding how inflammatory response may affect bioprosthetic and mechanical aortic replacement valves.All data were collected from a single mexican medical center between january 1995 and january 2020.The study population included 80 patients who were predominantly male with a mean age of 57 years.Multiple manufacturer¿s devices were implanted in the study population; 53 patients were implanted with a mechanical aortic valve, which included medtronic hall valves, and 27 patients were implanted with a bioprosthetic aortic valve, which included medtronic ats 3f valves.No unique device identifier numbers were provided.Among all patients, adverse events included: evidence of inflammation and prosthetic valve dysfunction resulting in anterior paravalvular leaks (pvl).Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC HALL PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 15721726
• MDR Text Key: 303035381
• Report Number: 2025587-2022-03068
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P790018
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A7700
• Device Catalogue Number: A7700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male