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

Model Number 500DM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)

Event Date 01/24/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding a (b)(6)-year-old female patient who six years prior received a medtronic ats 27-mm mechanical mitral valve for severe mitral stenosis.Unique device identifier numbers for the valve were not provided.Recently the patient presented with severe hypoxaemic respiratory failure caused by the sars-cov-2 infection, new-onset atrial fibrillation, and a massively dilated left atrium.Further evaluation found a mean transprosthetic gradient of 16 mmhg with likely pulmonary hypertension.Fluorography of the mechanical valve showed complete immobility of one of the leaflets and hypo-mobility of the other.A transesophageal ultrasound confirmed a hypoechogenic mass attached to one of the leaflets.Therapeutic anticoagulation by intravenous heparin and later a low dose iv thrombolysis alteplase was initiated to treat the suspected valve thrombosis.Subsequent testing showed normalized mobility of one of the valve leaflets, but the other remained immobile.A transthoracic echocardiogram showed a decrease in transprosthetic gradient of 4 mmhg.After further medicinal treatment, including beta-blockers and digoxin for atrial fibrillation management, the patient¿s clinical course was favorable and was discharged home a week later.At one year follow-up a transthoracic echocardiogram showed a transprosthetic gradient of 4 mmhg and asymptomatic permanent atrial fibrillation.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: jeckelmann et al.Case report: mechanical mitral prosthetic valve thrombosis in the context of covid-19 despite effective anticoagulation.Eur heart j case rep.2022 jan 24;6(2):ytac006.Doi: 10.1093/ehjcr/ytac006.Ecollection 2022 feb.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

April 5, 2022 - additional information received from the physician/author stated: 1) that no surgical intervention occurred, and 2) the patient's weight was 45 kg.

Manufacturer Narrative

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.

• Brand Name: OPEN PIVOT AP MITRAL HEART 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13911688
• MDR Text Key: 290291626
• Report Number: 2025587-2022-00809
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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: 04/05/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 45 KG