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

Model Number 25AGFN-756

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Thrombosis (2100); Obstruction/Occlusion (2422)

Event Date 03/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, an aortic valve replacement was performed where this 25 mm sjm regent mechanical heart valve was implanted.Postoperatively, there was suspicion of valve thrombosis.A transesophageal echocardiogram showed movement of a single leaflet.On (b)(6) 2015, the valve was explanted and at the time of surgery, thrombotic material was observed to be obstructing movement of one leaflet.The thrombotic material was sent to the hospital's pathology department.The valve was replaced with a 27 mm sjm epic supra tissue valve.The patient was reported to be stable postoperatively.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded both leaflets open and close completely, and there was mild limited mobility of one mechanical leaflet.The bottom rim section of the orifice contained a chip.The evenness of the coating and unremarkable nature of the material, ruled out any suggestion material defect.Rather, the orifice damage was caused by some external force applied to the orifice, which overstressed the carbon material.Detached pieces of thrombus material were received with the returned valve.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the mild limited mobility and thrombus 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 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4658691
• MDR Text Key: 5679685
• Report Number: 2648612-2015-00009
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P810002
• 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: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2019
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 4922392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2014
• 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: 57 YR