MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; REPLACEMENT HEART-VALVE

Model Number MDT-TISSUE VALVE

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Cardiac Tamponade (2226); Thromboembolism (2654)

Event Date 09/29/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding mid-term outcomes after surgical aortic valve replacement (savr) for aortic insufficiency (ai).All data were collected from a french and german medical center between may 2005 and december 2020.The study population included 289 patients who were predominantly male with a mean age of 57 years.Multiple manufacturer¿s devices were implanted in the study population; 33 patients were implanted with a medtronic hancock ii bioprosthesis and 12 patients were implanted with a medtronic freestyle bioprosthesis.No unique device identifier numbers were provided.Among all patients, post-operative mortality was 1.5% and overall mortality from ¿aortic valve-related deaths¿ was approximately 12.4%.No further details were provided on the deaths.Based on the available information medtronic product may have been associated with the valve-related deaths.Among all patients, adverse events included: endocarditis, requiring surgery and antibiotics; bleeding and cardiac tamponade requiring surgical intervention; mediastinitis; myocardial infarctions (mi); supraventricular tachycardia; need for permanent pacemaker implantation; strokes; thromboembolisms; moderate-severe structural valve deterioration (svd) and aortic bioprosthetic valve displacement, requiring surgical replacement.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.

Manufacturer Narrative

Citation: danial p.; et al.Outcomes of surgical bioprosthetic aortic valve replacement for aortic insufficiency.Arch cardiovasc dis.2022 nov;115(11):588-597.Doi: 10.1016/j.Acvd.2022.08.001.Epub 2022 sep 29.Pmid: 36272966 earliest date of publication used for date of event.Medtronic products referenced: hancock ii (pma# p980043, product code: dye); freestyle (pma# p970031, 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.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: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• 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: 16258042
• MDR Text Key: 308303542
• Report Number: 2025587-2023-00327
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970031
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• 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): Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG