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

Model Number MDT-MECH VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Host-Tissue Reaction (1297); Abortion (1688); Stroke/CVA (1770); Congenital Defect/Deformity (1782); Endocarditis (1834); High Blood Pressure/ Hypertension (1908); Insufficiency, Valvular (1926); Thrombosis (2100); Transient Ischemic Attack (2109); Blood Loss (2597); Thromboembolism (2654); Spontaneous Abortion (4514)

Event Date 04/19/2020

Event Type  Injury  

Manufacturer Narrative

Citation: guner a et al.Comparison of different anticoagulation regimens regarding maternal and fetal outcomes in pregnant patients with mechanical prosthetic heart valves (from the multicenter anatolia-preg registry).American journal of cardiology.2020; 127(issue):113-119.Doi: 10.1016/j.Amjcard.2020.04.010.Earliest date of publish used for event date.Medtronic products referenced: medhall mechanical heart valve (pma# p790018, product code lwq), open pivot mechanical heart valve (pma# p990046, product code lwq).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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the maternal and fetal outcomes of patients with mechanical heart valves and undergoing various anticoagulation regimens.All data were collected from multiple centers between january 1996 and august 2019.The study population included 110 patients (entirely female, mean age 30 years, a total of 155 pregnancies), an unknown number of whom were implanted with a medtronic medhall or ats (open pivot) mechanical valve (no serial numbers provided).Among all patients, 2 maternal deaths occurred.One patient who was on a regimen of low molecular weight heparin (first trimester) and warfarin (second and third trimester) suffered from a hemorrhagic cerebrovascular event and obstructive prosthetic valve thrombosis.The other patient who was on a regimen of low molecular weight heparin throughout the pregnancy died from an ischemic cerebrovascular event and disseminated intravascular coagulation.Multiple manufacturers were noted in the literature, and there was no association between the deaths and the heart valves.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: fetal loss (stillbirth, miscarriage, or abortion), preterm birth, congenital anomaly, thrombosis, cerebrovascular events, transient ischemic attack, thromboembolic complications, infective endocarditis, preeclampsia/eclampsia, major bleeding, hysterectomy, paravalvular leak, pannus formation.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10687800
• MDR Text Key: 211855047
• Report Number: 2025587-2020-03127
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P790018
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 09/16/2020
• 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): Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 30 YR