MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Corneal Pannus (1447); Chest Pain (1776); Death (1802)

Event Date 07/11/2020

Event Type  Death  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 23mm sjm regent heart valve w/flex cuff was selected for implant in a (b)(6) year old woman.The patient had a history of a bicuspid aortic valve, moderate coronary artery disease (lad 50%), a factor v leiden mutation, pulmonary embolism(2011) and is on lifelong warfarin therapy and severe aortic stenosis with a vmax 4.8 m/s and a mean gradient of 48mmhg.The patient had a pre-operative diagnosis of severe aortic valve stenosis and bicuspid aortic valve.The patient's native valve was a bicuspid valve with both leaflets significantly calcified and the annulus was extensively calcified.The aorta was thin-walled and the patient's right atrium was extremely fragile and pledgetted sutures were required to control the cannulation site.During the procedure, the annular calcification was meticulously debrided, the valve was sized and horizontal mattress sutures without pledgets were placed for the entire length of the aortic annulus.The valve was placed, the sutures were tied down and excellent seating was obtained.The native aortic valve was successfully replaced with no adverse events or patient consequences.The patient had a post-operative diagnosis of severe aortic valve stenosis and bicuspid aortic valve.The patient was discharged to home on (b)(6) 2020 in stable condition.The patient had a routine follow-up on (b)(6) 2020, and subsequently complained of non-specific symptoms of chest discomfort and coughing.Covid-19 testing was negative.The patient was found dead on (b)(6) 2020 and underwent an autopsy on (b)(6) 2020, which demonstrated tissue ingrowth into the mechanical heart valve limiting leaflet mobility.The cause of death was aortic valve disease.

Event Description

On (b)(6) 2020, a 23mm st.Jude medical regent mechanical heart valve with flexcuff was selected for implant in a 55-year-old woman with a history of a bicuspid aortic valve, moderate coronary artery disease (lad 50%), a factor v leiden mutation, and pulmonary embolisms in 2004 and 2011 on lifelong warfarin therapy.Other significant past medical history included obstructive sleep apnea on cpap, hypertension, dyslipidemia, and a hypercoagulable workup in 2011 revealing heterozygosity for factor v leiden mutation and homozygosity for mthfr gene mutation.The patient's prothrombin genotype was normal.Pre-procedure echocardiogram evaluation demonstrated severe aortic stenosis with an aortic valve area of 0.6 cm2 and a mean gradient of 48 mmhg with vmax 4.8 m/s.Intraoperative findings at the time of valve implant demonstrated a bicuspid native aortic valve with both leaflets significantly calcified and an annulus that was extensively calcified.It was noted that the aortic wall was thin with no palpable calcifications in the ascending aorta.During the procedure, the annular calcification was meticulously debrided, the valve was sized and horizontal mattress sutures without pledgets were placed circumferentially around the entire length of the aortic annulus.The prosthetic valve was manipulated onto the native annulus in the supra-annular position, sutures tied down, and excellent seating was obtained.Intra-operative manipulation of the mechanical heart valve leaflets by the surgeon demonstrated normal leaflet mobility.Intraoperative transesophageal echocardiography revealed a well seated aortic valve with good excursion of both leaflets and no paravalvular insufficiency.The patient tolerated the implant procedure well and was discharged to home on (b)(6) 2020 in stable condition on warfarin and baby aspirin with close monitoring of her inr level.The patient had a routine follow-up visit on (b)(6) 2020, and subsequently complained of non-specific symptoms of chest discomfort and coughing.Covid-19 testing was negative.The patient was found dead on (b)(6) 2020 and underwent an autopsy on (b)(6) 2020 in (b)(6), which demonstrated tissue ingrowth into the mechanical heart valve limiting leaflet mobility.

Manufacturer Narrative

The reported tissue ingrowth limiting leaflet mobility in a patient with a genetic predisposition for valve thrombosis (factor v leiden mutation) was confirmed.Histopathological analysis found inflow and outflow surface organizing thrombi with focal calcification but no acute inflammation.Pannus formation was noted on the sewing cuff and inflow orifice rim section which did not appear to extend and hinder leaflet mobility.Scratch marks were found on the inner flat of one pivot guard, consistent with tool damage incurred at explant.Four in-situ photographs of the valve were taken at the time of autopsy along with histological slides were also submitted for evaluation by the pathologist.These indicated that a larger quantity of tissue consistent with thrombus was present within the valve at the time the patient expired than was observed when the valve was returned to abbott for analysis, which hindered leaflet mobility and is consistent with a diagnosis of valve thrombosis.Hydrodynamic testing at the time of manufacturing and upon removal of the thrombus indicated that the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.Based on the totality of the data, there was no evidence of any intrinsic malfunction of the valve and the cause of the reported event is consistent with thrombus ingrowth into the leaflet pivot hinge mechanism impacting leaflet mobility.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 10481794
• MDR Text Key: 205266506
• Report Number: 3007113487-2020-00028
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 7100308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR