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

Model Number 21AGN-751

Device Problems Detachment Of Device Component (1104); Fracture (1260); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2014

Event Type  Injury  

Event Description

During an aortic valve replacement procedure, sutures were passed through the patient's annulus and the sewing cuff of this 21 mm valve.The valve, which was still attached to the valve holder, was placed into the patient's annulus.Due to difficult anatomy, the holder was removed.While tying the second suture, a central portion of one leaflet was observed to be missing.Therefore, it was concluded that a fracture occurred when tying the suture.The leaflet was unable to be located in the heart or filtering of the suction canister contents.The valve was removed and replaced with another 21 mm sjm regent valve utilizing the previously placed sutures.It was reported the patient has been discharged from the hospital.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded there was a fracture in one of the leaflets.No damage was observed to the orifice, recessed pivot areas, or other leaflet.The evenness of the coating and unremarkable nature of the material, ruled out any suggestion material defect.Rather, the fractured leaflet was apparently caused by some external force applied to the leaflet, which overstressed the carbon material.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 the analysis performed.

• 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: 4209543
• MDR Text Key: 5151646
• Report Number: 3007113487-2014-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PP810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2018
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 4137669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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: 62 YR