MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

Device Problems Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Citation: mandiye s.; et al.Consequences of mechanical and bioprosthetic heart valves replacement in tertiary care center of bhopal.Eur.J.Mol.Clin.Med.2022; 9(3):10169-10175.Https://ejmcm.Com/article_18244.Html earliest date of publication used for date of event.Medtronic products referenced: ats mechanical open pivot (pma# p990046, product code: lwq); hancock ii (pma# p980043, product code: dye).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 one medical center¿s experience with mechanical and bioprosthetic heart valve surgical replacements.All data were collected from a single indian tertiary care center between january 2018 and december 2021.The study population included 103 patients who were predominantly male with a mean age of 39 years.All patients were implanted with a medtronic valve, with 54 patients receiving an ats open pivot mechanical valve and 49 patients receiving a hancock ii bioprosthetic valve.No unique device identifier numbers were provided.Among all ats open pivot patients, three deaths occurred due to stuck leaflets from valve thromboses, resulting in low cardiac output, acidosis and eventually death, despite use of intravenous (iv) anticoagulant and thrombolytic agents.Based on the available info rmation medtronic product was associated with the deaths.Among all hancock ii patients, two deaths were noted, however no further information was provided.There was no statement of causal or contributory relationship between medtronic product and these deaths.Based on the available information medtronic product was not associated with these deaths.Among all ats open pivot patients, adverse events included: systemic thromboembolisms, anticoagulation-related bleeding resulting in severe anemia, melena and epistaxis, which required blood product transfusions, and need for re-operation due to stuck mechanical valve leaflets.Based on the available information medtronic product may have been] associated with the adverse events.Among all hancock ii patients, adverse events included: one case of systemic thromboembolism.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: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15671735
• MDR Text Key: 302400702
• Report Number: 3008592544-2022-00061
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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): Required Intervention; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male