MAUDE Adverse Event Report: CRYOLIFE, INC. PULMONARY VALVE & CONDUIT SG; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT

Model Number SGPV00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Endocarditis (1834)

Event Date 12/30/2021

Event Type  Injury  

Event Description

According to the implant summary card received from artivion administrative assistant, (b)(6), for sn: (b)(4) previously implanted tissue was explanted from a patient on (b)(6) 2021.A query of the artivion implant summary database produced (b)(4) serial number: (b)(4) which was implanted in the patient on (b)(6) 2021.The conduit only was used.Additional information provided by the artivion sales representative relayed that the graft was explanted on (b)(6) 2021 due to endocarditis.No additional information forthcoming.

Event Description

According to the implant summary card received from artivion administrative assistant, s.P., for sn: (b)(6) previously implanted tissue was explanted from a patient on (b)(6) 2021.A query of the artivion implant summary database produced sgpv00 serial number: (b)(6) which was implanted in the patient on (b)(6) 2021.The conduit only was used.Additional information provided by the artivion sales representative relayed that the graft was explanted on (b)(6) 2021 due to endocarditis.No additional information forthcoming.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 13572999
• MDR Text Key: 289878228
• Report Number: 1063481-2022-00003
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 162613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 15 YR
• Patient Sex: Male