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

Model Number 500DM

Device Problems Gradient Increase (1270); Mechanical Jam (2983)

Patient Problems Angina (1710); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Foreign Body Reaction (1868); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Citation: perzanowska-brzeszkiewicz k, et al.Severe dysfunction of a mechanical mitral valve prosthesis coexisting with non¿st segment elevation myocardial infarction.Kardiol pol.2021 mar 25;79(3):352-353.Doi: 10.33963/kp.15800.Epub 2021 feb 8.Earliest date of publish used for date of event.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 from a literature case report regarding a (b)(6) year-old female patient who had a st.Jude mechanical mitral valve replaced because of thrombosis with a 28 mm medtronic ats mechanical mitral valve.At an undisclosed time after ats valve implant, the patient presented to the authors facility with acute dyspnea and angina, having been referred from a different facility with suspicion of non-st segment elevation myocardial infarction (nstemi).Laboratory tests revealed elevated levels of cardiac biomarkers.Electrocardiogram exhibited st-t wave changes suggestive of nstemi; however, these changes were transient.Urgent transthoracic echocardiography revealed an immobile mitral prosthetic disc, with increased peak and mean gradients of 40 and 31 mm hg, respectively.In addition, left ventricular wall motion abnormalities were noted.Three dimensional transesophageal echocardiography revealed severe dysfunction of the ats mitral valve.One of the valve¿s discs was immobile due to a large (>1 cm) mass located on the ventricular side.Fluoroscopy confirmed obstruction of the ats mitral valve.Infusion of unfractionated heparin was started.On the eighth day after admission, cardiac surgery was performed.During the surgery, a thrombus and pannus were found on both sides of the ats valve, then the valve was explanted and replaced with a 27 mm medtronic hancock bioprosthetic valve.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12236267
• MDR Text Key: 263840165
• Report Number: 3008592544-2021-00032
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 07/14/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR