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

Model Number SGPV00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the implant summary card received via email on 23-oct-2020 from the user facility, the card is marked to indicate that cryolife tissue was explanted from the patient on (b)(6) 2020.(b)(6) 2020: a query of the cryolife implant database produce a sgpv00 that was implanted in the patient on (b)(6) 2012.The sgpv00 was used as a pulmonary valve during a ross procedure.This investigation is relegated to sgpv00 serial number: (b)(4) donor number: 115839.No product will be returned for evaluation.(b)(6) 2020: the cryolife sales representative relayed that the sgpv00 serial number: (b)(4).Was explanted due to endocarditis.The explanted valve was in great condition.The patient is doing fine.During the surgery, they replaced the aortic valve [the patient's native pulmonary valve - ross procedure] with a homograft [av00 sn: (b)(4) ] and a pulmonary valve [the sgpv00 sn: (b)(4) ] with sgpv00 [sn: (b)(4) ].No further information to follow.

Manufacturer Narrative

The homograft was implanted on (b)(6) 2012 into a 42-year-old male during a ross procedure.As such, the patient's pulmonary autograft was moved to the aortic position and the cryolife homograft was implanted into the pulmonary position.On (b)(6) 2020, approximately 8.5 years later, the patient presented with endocarditis of the cryolife homograft and underwent another surgery to remove the infected homograft as well as the "aortic (pulmonary autograft)" valve.At this time both valves were replaced with new homograft valves.Limited information is available regarding the details of the incident operation in 2012 or the redo procedure in 2020 including: patient demographics, implant and explant operative procedure notes, pertinent patient co-morbidities, past medical and surgical history, information and indication for the 2012 ross procedure, potential pertinent risk factors for recurrent endocarditis, if other heart valves were affected by the endocarditis, etc.In addition, the explanted tissue was not returned to cryolife for examination.Although the reason for the initial ross procedure remains unknown, rates of freedom from (recurrent) endocarditis suggests that homograft valves have an intrinsic resistance to infection early after the operation but is not immune to reinfection (bryne 2011, musci 2010, sabik 2002).The explant of the sgpv00 was due to endocarditis; despite the "valve being in great condition" as relayed from the cryolife field representative.The root cause of the endocarditis is unknown.The report of endocarditis over a year after implant makes an allograft/donor derived infection unlikely.Endocarditis has been reported with the use of cardiac homografts and is included in the cryovalve sg instructions for use.References: byrne et al.Ann thorac surg 2011;91:2012-9; musci et al.J thorac cardiovasc surg 2010;139:665-; 73sabik et al.Ann thorac surg 2002;74:650-9.

Event Description

According to the implant summary card received via email on (b)(6) 2020 from the user facility, the card is marked to indicate that cryolife tissue was explanted from the patient on (b)(6) 2020.(b)(6) 2020: a query of the cryolife implant database produce a sgpv00 that was implanted in the patient on (b)(6) 2012.The sgpv00 was used as a pulmonary valve during a ross procedure.This investigation is relegated to sgpv00 serial number: (b)(6); donor number: 115839.No product will be returned for evaluation.(b)(6) 2020: the cryolife sales representative relayed that the sgpv00 serial number: (b)(6) was explanted due to endocarditis.The explanted valve was in great condition.The patient is doing fine.During the surgery, they replaced the aortic valve [the patient's native pulmonary valve: ross procedure] with a homograft [av00 sn: (b)(6)] and a pulmonary valve [the sgpv00 sn: (b)(6)] with sgpv00 [sn: (b)(6)].No further information to follow.

• 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
• MDR Report Key: 10809661
• MDR Text Key: 215312089
• Report Number: 1063481-2020-00031
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• PMA/PMN Number: K092021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/22/2016
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 115839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR