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

Model Number MDT-MECH VALVE

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Liver Damage/Dysfunction (1954); Renal Failure (2041); Thrombosis/Thrombus (4440); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Citation: liu p et al.Which is the best prosthesis in an isolated or combined tricuspid valve replacement? european journal of cardio-thoracic surgery.2021; 59:170-179.Doi: 10.1093/ejcts/ezaa273.Earliest date of publish used for event date.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a retrospective comparison of outcomes of patients undergoing a tricuspid valve replacement with a bioprosthetic or mechanical valve, with or without a concomitant surgery on the left side of the heart.All data were collected from two centers between january 1999 and december 2018.The study population included 338 patients (predominantly female, mean age 41.3 years), 7 of whom were implanted with medtronic mechanical valve (unique device identifier numbers not provided).Among all patients, 9 deaths occurred within 30 days of implant due to cardiac failure related to severe depression of myocardial function.Throughout the follow-up period, 91 other patients died due to cardiac reasons (58 patients), low cardiac output syndrome (21 patients), valve-related complications (37 patients), and non-cardiac reasons (33 patients).Multiple manufacturer¿s devices were implanted in the study population, and no association was made between the deaths and a specific manufacturer¿s devices.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: right-sided heart failure, liver failure, renal failure, infection, bleeding, complete heart block requiring a permanent pacemaker, cerebrovascular accident, pulmonary hypertension, thrombosis, structural valve deterioration, severe tricuspid regurgitation, pannus formation, endocarditis.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 SURGICAL MECHANICAL 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12393088
• MDR Text Key: 268976804
• Report Number: 2025587-2021-02700
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MDT-MECH VALVE
• Device Catalogue Number: MDT-MECH VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR