MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Hemolytic Anemia (2279); Syncope/Fainting (4411); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a pregnant patient with a mechanical heart valve implanted one year prior had the valve explanted due to device thrombosis.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.It was indicated that the patient was compliant with their blood thinning medication and that the fact that the patient was pregnant put them into a prothrombotic state, increasing the risk of thrombosis of the valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "the multidisciplinary management of a mechanical mitral valve thrombosis in pregnancy : report of a case", was reviewed.The research article presents a case study of a 39-year-old primigravid female.Who was referred for management of a mechanical heart valve (mhv) in pregnancy.The patient had a history of rheumatic heart disease with symptomatic severe mitral stenosis, severe tricuspid regurgitation, severe left atrial enlargement, type ii pulmonary hypertension, and chronic atrial fibrillation.One year prior to pregnancy, the patient had undergone a 33 mm st-jude bi-leaflet metallic mitral valve replacement, tricuspid valve annuloplasty, and an amputation of the left atrial appendage containing a large thrombus discovered intraoperatively.A mechanical valve was chosen because of its longer durability in light of the patient¿s young age, and the presence of another indication for anticoagulation (i.E., atrial fibrillation) (4, 6).At the time, the patient had no future pregnancy plans.The patient's surgery was well tolerated and without complications.The patient was adherent to the antithrombotic regimen, which consisted of daily oral warfarin 5 mg (targeting an 7 inr of 2.5-3.5) since surgery.At four weeks of gestation, the patient's warfarin was discontinued due to teratogenicity concerns, and was switched to low molecular weight heparin (lmwh).Aspirin 81 mg orally daily was added at 10 weeks as an adjunct antithrombotic therapy.The patient was referred for multidisciplinary high-risk pregnancy care at our tertiary healthcare center at 12 weeks of gestation.The potential anticoagulation strategies for the remainder of the pregnancy were reviewed, along with an in-depth discussion regarding their associated risks and benefits.It was decided that lmwh was to be continued (i.E., enoxaparin 1 mg/kg sc bid) due to its better fetal safety.The patient's anti-xa levels were measured every 1-2 weeks, and a transthoracic echocardiogram (tte) at 17 weeks demonstrated the mechanical mitral valve in situ with a mean transvalvular gradient of 4 mmhg, mild-moderate mitral regurgitation, severe left atrial dilatation, and normal biventricular systolic function and pulmonary artery pressure.At 30 weeks of gestation, the patient presented to the emergency room with an acute onset of dyspnea, orthopnea, bilateral lower extremity edema, and a new cough with scant hemoptysis.Blood pressure was 110/71 mmhg, heart rate was 100-115 beats per minute (sinus rhythm), and oxygen saturation ranged between 88-91% on room air.The patient was afebrile.Chest x-ray revealed pulmonary edema.A tte was performed emergently and demonstrated a mass of 2.58 cm in diameter on the ventricular lateral aspect of the mitral valve prosthesis with some multi lobulated mobile projections, and a diastolic mean gradient of 28 mmhg.The mass was concerning for mhv thrombosis.The differential diagnosis included infective endocarditis and myxoma, albeit these diagnoses were felt to be less likely in the give clinical context.Nevertheless, empiric antibiotics were started with gentamycin and vancomycin pending blood culture results.The position of the mass and the rapidity with which it developed (i.E., within one year of cardiac surgery) made a myxoma highly improbable.The patient was admitted to the intensive care unit for monitoring, diuresis, and anticoagulation with intravenous (iv) unfractionated heparin.After 48h, a repeat tte and transesophageal echocardiography were performed which redemonstrated the large mass.The mitral valve mean gradient had decreased from 28 mmhg to 20 mmhg (heart rate of 72 bpm), however the mass size remained unchanged.It was decided that the patient would undergo a caesarean section followed immediately by cardiac surgery to replace the mitral valve.The patient¿s iv heparin was held for 4 hours in preparation for surgery.However, a repeat tte revealed an increase in the size and mobility of the mass, and an acute worsening of the diastolic mean gradient to 34 mmhg at 84 bpm.Therefore, anticoagulation was immediately restarted, and the caesarean section was performed while on therapeutic iv heparin.The high risk nature of the surgical plan necessitated careful logistical organization before proceeding to the operating room.The caesarean section was performed.Bleeding was surgically cauterized to optimize hemostasis.A live baby boy weighing 1,560 g was delivered.The placenta was delivered manually, and the uterus was closed in one layer.Estimated 500-600 cc of blood during the caesarean section and an additional 800 cc was measured by the intrauterine foley catheter during the cardiac surgery.The patient received three units of packed red blood cells before proceeding to cardiac surgery.The patient then underwent a redo sternotomy to replace the mhv prosthesis.Cardiopulmonary bypass was established using femoral artery cannulation and bicaval venous cannulae.A 31 mm st.Jude epic bioprosthetic valve replaced the previous mechanical mitral valve.The rationale for choosing a bioprosthetic valve instead of a mechanical valve despite her age was in the event of post-operative bleeding requiring interruption of anticoagulation (as occurred in this case), which would pose a particularly high risk of thrombosis in the early post operative and postpartum periods.The patient remained stable coming off cardiopulmonary bypass.Intravenous protamine was given to reverse the effect of heparin.A thrombus was confirmed upon pathological examination.In the icu, vasopressor requirements increased postoperatively with a drop in hemoglobin from 94 g/l to 57 g/l.Chest imaging revealed a large loculated right hemothorax causing leftward mass effect, active arterial extravasation in the superior anterior mediastinum, and a displaced chest tube.Thus, the patient was taken back to the operating room on postoperative day one for surgical exploration.No bleeding source was identified, but a large amount of blood and clots were evacuated from the right pleural space.While hemodynamic status rapidly normalized following surgery, the patient developed an expanding rectus sheath hematoma measuring up to 11 x 9 x 11 cm on postoperative day four.It improved with expectant management while receiving prophylactic dose dalteparin.Anticoagulation with warfarin targeting an inr of 2-2.5 was initiated on post-operative day 12 for valvular atrial fibrillation.The patient otherwise recovered well and was discharged home after a 28-day hospital stay.[the primary author of the article is isabelle malhamé, md msc frcpc assistant professor, department of medicine mcgill university health centre 1001, boul.Décarie, d05.5839.3, montréal, québec, canada, h4a 3j1 telephone: (b)(6) email: (b)(6)].

• Brand Name: UNKNOWN MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17326299
• MDR Text Key: 319274769
• Report Number: 2135147-2023-03034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Female