MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 17AGFN-756

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, a double valve replacement (dvr) was performed and this 17 mm regent mechanical heart valve was implanted in the aortic position utilizing non-everting mattress sutures and a 29 mm sjm mechanical heart valve (model and sn unknown) was implanted in the mitral position.Postoperatively, a follow-up echocardiogram was performed every 6 months.The patient visited the hospital for the monitoring of the international normalized ratio (inr) of prothrombin time every 3 months as an outpatient.The level of inr had been maintained at 2.0, and a range from 1.7 to 1.8, with the lower end at the time there was a tendency to hemorrhage was observed.Reportedly, steroids had been administered.Since (b)(6) 2016, the postoperative course had been uneventful despite the observation of mild paravalvular leakage (pvl).On (b)(6) 2017, the patient's condition suddenly became worse and the patient presented to the hospital.Contrast radiography revealed that one of the leaflets of the aortic valve had dislodged and acute aortic regurgitation (ar) was observed.The dislodged leaflet appeared to be at the bifurcation of the left common iliac artery (lt-cia) via computed tomography (ct).Emergent re-do avr was performed and the valve was explanted.At explant, a portion of the fractured leaflet was found in the common iliac artery.The dislodged leaflet was also removed from the bifurcation of lt-cia.After removal, the surgeon noticed that the dislodged leaflet was fractured and that a small piece of the leaflet could not be found during surgery and was likely remains in the patient.An 18 mm ats open pivot bileaflet heart valve (medtronic, model: ap-18) was implanted.The mechanical heart valve in the mitral position remained implanted with no issues.Postoperatively, the patient has been monitored in stable condition with no symptoms of thrombosis.

Manufacturer Narrative

The results of this investigation indicated there was no evidence of material defect in the carbon coating that may have caused or contributed to the leaflet fracture, dislodged leaflet, and orifice damage.Rather, the leaflet fracture, dislodged leaflet, and orifice damage was caused by some external force applied to the valve which overstressed the carbon material.Fibrous tissue was found on the sewing cuff, and no inflammation or significant calcification was observed.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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: 6385878
• MDR Text Key: 69327396
• Report Number: 2648612-2017-00031
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2016
• Device Model Number: 17AGFN-756
• Device Catalogue Number: 17AGFN-756
• Device Lot Number: 3518342
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 43 YR