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

Model Number	25VAVGJ-515
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficiency, Valvular (1926)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021, valvular leak was confirmed post implant from the junction of the mechanical heart valve to valsalva graft after leaving procedure room.The surgeon had to take the patient back to the operating room and repair the leak area with proline suture size 4/0.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 h10.The reported event of a leak in the junction between the graft and valve could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.While the cause of the event could not be established, the warnings section of the instructions for use artmt100104849 rev.A, contains multiple items for guidance to mitigate potential for damage of the valve graft." do not use cutting edge or cutting point needles in the sewing cuff or valve graft.Use of standard round or taper point needles is recommended to prevent cutting the polyester fibers." "avoid excessive manipulation of the sjm masters hp valve graft.If surgical technique requires cross-clamping of the graft, cover the jaws of the clamp with soft tubing to prevent damage to the valve graft." "gently extend the graft lengthwise until the crimps are flat.Avoid excessive tension on the sjm¿ masters hp valve graft." "gently extend the graft lengthwise until the crimps are flat.Avoid excessive tension on the sjm¿ masters hp valve graft." "if a needle is used to de-air the sjm masters hp valve graft, use the smallest possible needle.19 gauge needles are normally sufficient.Use of larger needles or hypodermic needles may result in blood leakage, and repair by suturing may be required." needle is used to de-air the sjm masters hp valve graft, use the smallest possible needle.19 gauge needles are normally sufficient.Use of larger needles or hypodermic needles may result in blood leakage, and repair by suturing may be required.".

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• 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: 11174982
• Report Number: 2648612-2021-00001
• Device Sequence Number: 2840983
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 07/31/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 7100242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/05/2021
• 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
• Patient Age: 56 YR
• Patient Weight: 175