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

Model Number 23AGFN-756

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the 23 mm sjm regent valve was successfully implanted in a (b)(6) year-old patient.Ten days post implant on an echocardiogram, one leaflet of the aortic prosthesis was observed to have reduced movement.On (b)(6) 2015, the patient underwent exploratory surgery and a leaflet tester was used to assess the valve leaflets, which appeared to be correctly working.However, based on the echo result, the surgeon elected to rotate the leaflets 90°.Several hours after the rotation of the valve, a transesophageal echocardiogram revealed the leaflets were not functioning well.The valve was explanted and replaced with a 23 mm sjm masters series valve.The patient condition was reported to be good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The investigation concluded there was no evidence found to suggest there was 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 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 ; 6517565400
• MDR Report Key: 4818258
• MDR Text Key: 20730135
• Report Number: 2648612-2015-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 4389243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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: 23 YR
• Patient Weight: 108