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

Model Number	SGPV00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the implant summary card returned from the user facility indicating that cryolife tissue was explanted from a patient on (b)(6) 2021.A query of the cryolife implant tracking database revealed the patient had a sgpv00 serial number: (b)(4) implanted on (b)(6) 2018.
Event or Problem Description
According to the implant summary card returned from the user facility indicating that cryolife tissue was explanted from a patient on (b)(6) 2021.A query of the cryolife implant tracking database revealed the patient had a sgpv00 serial number: (b)(6) implanted on (b)(6) 2018.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Common Device Name: 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: 12745055
• Report Number: 1063481-2021-00031
• Device Sequence Number: 4714155
• Product Code: OHA
• UDI-Device Identifier: 00877234000447
• UDI-Public: 00877234000447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2021

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
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 147078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/18/2021
• Date Device Manufactured: 12/18/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male