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

Model Number	25VAVGJ-515
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Valve sticking.

• Brand Name: SJM MASTERS SERIES HP GELWEAVE VALSALVA
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 18147748
• Report Number: 18147748
• Device Sequence Number: 18018190
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: (01)05414734009492
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/09/2023
• Report Date (Section F): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 19549755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White
• Date Report Sent to FDA: 11/09/2023