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

Model Number 21AJ-501

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Aortic Regurgitation (1716); No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 21mm masters valve was implanted in the aortic position.Three months post surgery during a follow-up visit, the patient was confirmed to have severe regurgitation.The physician believed the 21mm valve was inappropriate size for the patient.On (b)(6) 2018, the device was explanted.The patient had elevated differential pressure gradient across the valve during the explant procedure and was administered warfarin to stabilize.The device was successfully replaced with a 23mm masters valve.The patient is reported to be stable.

Event Description

It was initially reported that the reported valve was explanted after an implant period of about 3 months.Based on a follow-up conversation with the physician, it was confirmed that this 21mm masters valve was selected for implant, but determined to be the incorrect size so the device was exchanged to complete the procedure.The device was never implanted in the patient.

Manufacturer Narrative

An event that the physician chose the improper valve size and did not implant the valve was reported.No damage or other anomalies were found on the valve and there was no evidence of implant, consistent with information from the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the mis-sizing event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• 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
• MDR Report Key: 8404483
• MDR Text Key: 138258345
• Report Number: 2648612-2019-00019
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734021104
• UDI-Public: 05414734021104
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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: 04/30/2019
• Device Model Number: 21AJ-501
• Device Catalogue Number: 21AJ-501
• Device Lot Number: 4590697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention