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

Model Number 500DM

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Obstruction of Flow (2423); Incomplete Coaptation (2507); Mechanical Jam (2983)

Patient Problems Host-Tissue Reaction (1297); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Insufficiency, Valvular (1926); Unspecified Infection (1930); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Renal Failure (2041); Sepsis (2067); Thrombus (2101); Heart Failure (2206); Regurgitation (2259); Stenosis (2263); Regurgitation, Valvular (2335); Blood Loss (2597); Complete Heart Block (2627)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Citation: park b et al.Clinical implication of transaortic mitral pannus removal during repeat cardiac surgery for patients with me chanical mitral valve.Circ j.2018 jan 25;82(2):396-402.Doi: 10.1253/circj.Cj-17-0463.Epub 2017 aug 31.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the safety and feasibility of transaortic mitral pannus removal in patients with rheumatic heart disease on the ventricular side of a mechanical mitral valve through the aortic valve.All data were collected from a single center between february 2004 and december 2016.The study population included 34 patients (predominantly female; mean age 57 years), 6 of which were implanted with a 27 mm medtronic open pivot mechanical valve, 4 were implanted with a 29mm medtronic open pivot mechanical valve, and 3 were implanted with a medtronic med hall easy-fit mechanical heart valve.No serial numbers were provided.The article defined an early event as any event occurring within 30 days of the surgery.Among all patients, there were no early deaths.There were 4 late deaths: 1 due to heart failure, sepsis from endocarditis in 1 patient, 1 due to chronic renal failure, and death of unknown cause in 1 patient.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, early adverse events included: 2 permanent pacemaker implantations for heart block and sick sinus syndrome, 1 reoperation because of bleeding, and 1 case of mediastinitis.Other adverse events included: pannus formation, mechanical mitral valve replacement, mitral valve paravalvular leakage and leakage closure, eccentric mitral regurgitation, aortic regurgitation, thrombus, stenosis, high transprosthetic mean pressure gradients, complete immobilization of one cusp, delayed mechanical valve leaflet closure, and extracorporeal membrane oxygenation for cardiac arrest.Late adverse events noted in the article included: 5 cases of cerebral hemorrhage, 2 cases of endocarditis (1 resulting in reoperation and 1 requiring medical treatment), 2 permanent pacemaker implantations for sick sinus syndrome and 1 case of mild mitral paravalvular leakage.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.Among all patients that received a med hall mechanical valve, device malfunctions included: aortic regurgitation caused by acute malfunction of the mechanical mitral valve.Based on the available information, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT AP MITRAL 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7690365
• MDR Text Key: 114074464
• Report Number: 3008592544-2018-00022
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Age: 57 YR