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

Model Number 21CAVGJ-514 00

Device Problem Biocompatibility (2886)

Patient Problem Thrombus (2101)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 201324000
• Report Number: 2648612-2020-00081
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006026
• UDI-Public: 05414734006026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention