MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,23MM; MASTERS SERIES AORTIC VALVED GRAFT

Model Number	23CAVGJ-514 00
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 23 mm masters series aortic valved graft was chosen for implant.Once the valve was implanted and the patient was removed from bypass, a blood leak was observed.The valve was replaced with another 23 mm masters series aortic valved graft was successfully implanted.No patient consequences were reported.
Additional Manufacturer Narrative
An event of ¿a blood leak was observed from the graft¿ was reported.The returned 23mm masters series aortic valved graft met abbott specifications with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2018, a 23mm masters series aortic valved graft was chosen for implant.Once the valve was implanted and the patient was removed from bypass, a blood leak was observed from the graft.The valved graft was replaced with another 23mm masters series aortic valved graft.The procedure was successfully completed without further bleeding.No patient consequences were reported.

• Brand Name: MASTERS SERIES CAVGJ,AUS TRALIAN,23MM
• Common Device Name: MASTERS SERIES AORTIC VALVED GRAFT
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 7662764
• Report Number: 2648612-2018-00053
• Device Sequence Number: 2527457
• Product Code: LWQ
• UDI-Device Identifier: 05414734006149
• UDI-Public: 05414734006149
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 12/12/2022
• Device Model Number: 23CAVGJ-514 00
• Device Catalogue Number: 23CAVGJ-514 00
• Device Lot Number: 6248147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: Other
• Patient Age: 37 YR