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

Model Number 25AJ-501

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on (b)(6) 2021, a 25mm aortic sjm masters series mechanical heart valve was implanted in the mitral position.The physician had intended to implant a 25mm mitral sjm masters series mechanical heart valve.When the valve was implanted in the mitral position and the patient was taken off bypass, it was noted that the patient's heart was not beating properly.After further diagnosis and confirmation, it was determined that the implanted valve was a 25mm aortic sjm masters series mechanical heart valve.The incorrect aortic sjm masters series mechanical heart valve was explanted and replaced with a new 25mm sjm masters series mechanical heart valve.There was a clinically significant delay in procedure due to the incorrect valve being implanted.The patient is reported to be in stable condition and is being monitored.Additional information is pending.

Manufacturer Narrative

Additional information: d9, h3, h6.The reported event of an aortic valve being found in a mitral valve box and implant of that valve in the mitral position was reported.Information from the field indicated that the tray inside the mitral valve box was labeled with an aortic valve label and that the qa seal of the box was "damaged" prior to implanting the valve.The investigation found that the returned valve, which had blood on it consistent with implant of the device, was an aortic valve; the sewing cuff contained three suture marks as opposed to the four on a mitral valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including the qa seal being intact prior to shipment.Information from the field indicated that the device with sn (b)(6) (aortic) was found inside the box for device sn (b)(6) (mitral) and that the reverse was also true.Both shelf boxes had damaged qa seals when examined prior to use, with imaging being received from the field which appeared to show the qa seal of the aortic valve box was cut open when it was found in storage.Information from the hospital determined that they examine the packaging for damage prior to accepting the devices for storage.In addition, the devices were manufactured 9 months apart and were shipped in separate shipments to the hospital, one month apart.Neither device was reworked after their initial manufacture and placement of the qa seal on the box.Both devices were stored in the same "safe" at the hospital.Based on the information received, the cause of the reported incident appears to be consistent with the devices being opened in the field and being accidentally replaced in the incorrect box.Please note, per the instructions for use, (b)(4) rev.A, "warnings do not use if the tamper-evident container seal or inner/outer tray seals are damaged, broken or missing." and "three suture markers on aortic sewing cuff.".

• Brand Name: SJM MASTERS SERIES MECHANICAL 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12439258
• MDR Text Key: 270306109
• Report Number: 3007113487-2021-00029
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734021128
• UDI-Public: 05414734021128
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25AJ-501
• Device Catalogue Number: 25AJ-501
• Device Lot Number: 7763015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• 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): Required Intervention