MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	29VAVGJ-515
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of a leaflet dislodging during explant was reported.The results of the investigation are inconclusive since 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.
Event or Problem Description
On (b)(6) 2019 a leaflet of a masters mechanical valve dislodged during explant.Leaflet was retrieved by doctor.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 9829696
• Report Number: 3007113487-2020-00004
• Device Sequence Number: 16325580
• Product Code: LWQ
• UDI-Device Identifier: 05414734009508
• UDI-Public: 05414734009508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 6013408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/13/2020
• 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