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

Model Number	21AJ-501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2648612-2019-00019
• Device Sequence Number: 1975536
• Product Code: LWQ
• UDI-Device Identifier: 05414734021104
• UDI-Public: 05414734021104
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention