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

Model Number 21AGN-751

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 02/23/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, an aortic valve replacement procedure was performed and as this 21 mm sjm regent valve was placed in the aortic root, a cracking sound was heard.It was reported the holder was still on the valve.During rotation, both leaflets dislodged and fell into the patient's left ventricle.The leaflets and valve were removed and a new 21 mm sjm regent valve was implanted successfully.A few hours post procedure, the patient died due to heart failure caused by bleeding.It was reported the surgeon indicated the death had no connection with valve or replacement procedure.

Manufacturer Narrative

(b)(4).The results of this investigation concluded both leaflets were dislodged and the orifice was fractured.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.This investigation indicated the evenness of the coating and unremarkable nature of the valve material, ruled out any suggestion of material defect.Rather, the dislodged leaflets and orifice damage was caused by some external force applied to the leaflets and orifice, which overstressed the carbon material.There was no evidence found to suggest the cause of the dislodged leaflets and orifice damage were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5498113
• MDR Text Key: 40231597
• Report Number: 3007113487-2016-00026
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 4687424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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; Required Intervention
• Patient Age: 74 YR