MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM REGENT¿; HEART-VALVE, MECHANICAL

Model Number AGFN-756

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/17/2017

Event Type  malfunction  

Event Description

Patient was admitted for severe swelling in his lower extremities, buttocks and scrotal area.He self-medicated at home with lasix 20 mg with some improvement of his symptoms.His symptoms recurred when he ran out of lasix, accompanied with shortness of breath.When symptoms worsened, he came to the hospital he was found to have acute on chronic heart failure and was diuresed.His workup revealed severe aortic valve regurgitation.On cardiac catheterization, there was no significant coronary disease, and was subsequently referred for aortic valve replacement.Aortic valve replacement was done approximately five months ago with the following excerpts from the operative report: as we were sequentially securing down the valve, periodically we would use a cotton tip applicator to make sure there were no pledgets exposed underneath and to make sure the leaflets were not obstructed in any way.When we did this, one of the two leaflets became unhinged and a small triangular piece of the valve fell off.The valve was thus explanted and care was taken to remove any free pledgets and to ensure no other pieces of the valve were left behind.The annular stitches were replaced and the valve was resized.The hospital did not have a second 27 mm st.Jude regent valve.We sized alternatively with the st.Jude master mechanical valve sizer.This revealed a 29 mm size was appropriate.This was once again well within the acceptable area (green) for effective orifice area given this patient's bsa.The valve was then seated as described above, without issues.

• Brand Name: SJM REGENT¿
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b e; saint paul MN 55117
• MDR Report Key: 6773589
• MDR Text Key: 82041989
• Report Number: 6773589
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AGFN-756
• Device Catalogue Number: 27AGFN-756
• Other Device ID Number: 29 MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 64 YR
• Patient Weight: 98