MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,21MM

Model Number	21CAVGJ-514 00
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
In 2016, a 21mm masters series cavgj mechanical valve was implanted.On (b)(6) 2020, the valve was explanted due to thrombus that was unable to be removed via thromboembolisation.A competitor's 23mm sorin conduit valve was successfully implanted.The patient is reported to be in stable condition.
Additional Manufacturer Narrative
Explant was reported due to thrombus.The investigation found that both mechanical leaflets were dislodged from the orifice.One was fractured.There was a tiny piece of white material within on recessed pivot area, which was too small to sample.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: MASTERS SERIES CAVGJ,AUS TRALIAN,21MM
• Common Device Name: MASTERS SERIES CAVGJ,AUS TRALIAN,21MM
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10343951
• Report Number: 2648612-2020-00081
• Device Sequence Number: 19047457
• Product Code: LWQ
• UDI-Device Identifier: 05414734006026
• UDI-Public: 05414734006026
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: 21CAVGJ-514 00
• Device Catalogue Number: 21CAVGJ-514 00
• Device Lot Number: 4921534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Hospitalization; Required Intervention