MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number CVD0039

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Not being returned.

Event Description

The following information comes from the abstract of the "the 53rd annual meeting of japanese society of pediatric cardiology and cardiac surgery" 2017 vol.33, supplement 1, page s1-394, iii-p38-05.Title: a thrombolytic therapy with recombinant tissue plasminogen activator (rt-pa) for the treatment of prosthetic valve thrombus after mitral valve replacement (mvr) in a (b)(6) old male infant.On an unknown date, a mitral valve replacement (mvr) was performed and a 17mm mechanical heart valve intended for the aortic position (model and serial unknown) was implanted in a (b)(6) old infant with idiopathic chordal rupture of mitral valve.Repeat surgery was required and the small size aortic valve was placed in the inverted position in the patient's mitral position.The postoperative course is uneventful with recovery of cardiac function.However it was difficult for this patient to be controlled with warfarin.The 36th postoperative day, at the time of discharge from the hospital, international normalized ratio of prothrombin time (pt-inr) was noted to be 2.7, low control of 1.4 to 2.0 as an outpatient.The inflow velocity of left ventricle was elevated from 1.0 to 1.8 m/s at maximum.At the time of two and a half months follow-up, x-ray imaging revealed that one leaflet of this valve had been stuck in the closed position.The patient was immediately admitted to this hospital.As the physician deemed that one leaflet to be immobile was caused by thrombus formation, thrombolytic therapy was conducted.Then, low volume of recombinant tissue-type plasminogen activator (rt-pa/ alteplase, 0.1mg/kg/h) was continuously administered with heparin.After administration of rt-pa for 64 hours,the leaflet mobility was confirmed to improve, the treatment of rt-pa was discontinued.Heparin, aspirin and warfarin were administered instead.The range of pt-inr became 1.2 to 2.1 but was unable to be controlled properly.Three weeks after rt-pa was discontinued, recurrence of prosthetic valve thrombus was confirmed through a x-ray imaging.Administration of rt-pa was re-started.Two days after rt-pa was re-administered, a repeated x-ray imaging revealed that thrombosis was resolved.The target range of pt-inr was set as 2.5 to 3.0.Subsequently, the leaflets of this valve were noted to be mobile/normal.No bleeding complication was observed throughout a course of treatment.The author stated that as rt-pa has high affinity for fibrin and thrombolysis efficacy, any risk of adverse effect of bleeding is recognized to be low.Thus thrombolysis therapy with rt-pa is able to be conducted safely in infant patients with prosthetic valve thrombus.No additional information is available.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6903766
• MDR Text Key: 87754477
• Report Number: 2648612-2017-00079
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CVD0039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 9 MO