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

Model Number	27MJ-501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Thrombus (2101); No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 27mm masters valve was implanted in the mitral position.During the three month follow-up, the patient was confirmed to have severe regurgitation which required intervention.On (b)(6) 2018, the device was explanted.The patient didn't remain hemodynamically stable throughout the procedure; the cross-valve differential pressure was high.The patient was administered additional warfarin to stabilize.The physician believes the regurgitation was due to the size of the valve.Per the physician there was thrombus on the device.The device was replaced and a 29mm masters valve was implanted.The patient was stable post-operatively.
Additional Manufacturer Narrative
An event that the physician chose the improper valve size and while handling the valve before implant the valve fell to the floor 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 and contamination event could not be conclusively determined.
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 27mm valve was selected for implant, but determined to be the incorrect size.As the device was exchanged the device fell onto the floor.The procedure was completed with a replacement device.The reported device was never implanted in the patient.

• 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: 8404667
• Report Number: 2648612-2019-00020
• Device Sequence Number: 18937634
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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): 05/21/2019

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: 04/18/2023
• Device Model Number: 27MJ-501
• Device Lot Number: 6417419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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