MAUDE Adverse Event Report: ARTIVION, INC. ¿ KENNESAW 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	Aortic Valve Insufficiency/ Regurgitation (4450)
Type of Reportable Event	Serious Injury
Additional 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 artivion is accurate or has been confirmed by artivion.
Event or Problem Description
According to the initial notification, "the publication titled ¿fifty-two months¿ mean follow up of decellularized synergraft¿-treated pulmonary valve allografts¿ the journal of heart valve disease 2008;17:98-104: it is a retrospective review which compares synergraft® pulmonary valves (cryolife®, sgpv00) to standard processed cryopreserved pulmonary valves (controls, unknown processor) used for the ross procedure.The manuscript covers implants from 2000 ¿ 2002, with the use of 23 sgpv compared to 49 standard processed valves.Regurgitation (insufficiency) was noted in the sgpv recipients, and also noted to be higher than that seen in the control group.The authors conclude it appears that the use of pulmonary synergraft-allograft valves does not provide any major advantage over conventional allografts.".
Additional Manufacturer Narrative
Multiple attempts to obtain additional information have gone unmet.No additional information forthcoming.The available information was reviewed.According to the initial notification on 10/07/2024, "the publication titled ¿fifty-two months¿ mean follow up of decellularized synergraft¿-treated pulmonary valve allografts¿ the journal of heart valve disease 2008;17:98- 104.The manuscript written by bechtel, et al.Is a retrospective review which compares synergraft® pulmonary valves (cryolife®, sgpv00) to standard processed cryopreserved pulmonary valves (controls, unknown processor) used for the ross procedure.The manuscript covers implants from 2000 ¿ 2002, with the use of 23 sgpv compared to 49 standard processed valves.Regurgitation (insufficiency) was noted in the sgpv recipients, and also noted to be higher than that seen in the control group.The authors conclude it appears that the use of pulmonary synergraft-allograft valves does not provide any major advantage over conventional allografts." the manuscripts by bechtel et al., is a retrospective review reporting on the outcomes of synergraft® pulmonary valves (cryolife®, sgpv00) used during the ross procedure.The patients underwent pre and post-operative echocardiographic evaluations over the span of the 52 months follow-up.The patients showed the main increase of pressure gradients within the first year after surgery but remained stable through the remainer of the follow-up.No reoperations were required on any of the patients as such there was no tissue explant available for further evaluation.The authors discuss potential causes to be a destructive immunological process or a non-specific inflammatory response contributing to allograft failure.No additional information is available regarding the specific time to occurrence of this event for each patient or direct correlation to the use of the allografts.The cardiac allografts undergo inspection by the dissector as well as by the inspector prior to final packaging.The instructions for use (ifu) lists valvular and perivalvular insufficiency (regurgitation), immunologic reaction and valvular and conduit stenosis as known adverse events with the use of cardiac allografts and have been reported with other heart valve prostheses and should be considered in the decision of graft selection.Due to the limited information, it cannot be determined if the reported events are directly related to the allografts given there were no explants noted in the follow-up period nor any immunologic evaluations were confirmed.The adverse events reported in the publications are not unexpected clinical outcomes of the allografts in this patient population.Adequate precautions are listed in the ifu.The sg cryopreserved human tissue a/dfmea was reviewed.The reported event is addressed.The sg cryopreserved human tissue pfmea was reviewed.The reported tissue was not returned to artivion and no serial number was provided for an investigation.The report originated from a publication which spanned from 2000-2002.This complaint reports adverse events (ae) identified in literature and does not specify potential causes of failure.Due to the limited information and unknown time to events, it cannot be determined if the reported events are directly related to the allografts.As such, no risk occurrence analysis was performed in this report.Due to the limited information, it cannot be determined if the reported events are directly related to the allografts given there were no explants noted in the follow-up period nor any immunologic evaluations were confirmed.The adverse events reported in the publications are not unexpected clinical outcomes of the allografts in this patient population.Adequate precautions are listed in the ifu.The reported event will continue to be monitored for trends.No updates to the rmf are needed in response to this complaint.Risk has been reduced as low as possible and overall residual risk is acceptable.There is no indication that an error or deficiency occurred at artivion and the ifu adequately communicates risk; therefore a capa evaluation is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.No actions are required at this time.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 artivion is accurate or has been confirmed by artivion.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Common Device Name: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts boulevard. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard, nw; kennesaw, GA 30144
• MDR Report Key: 20462898
• Report Number: 1063481-2024-00021
• Device Sequence Number: 12711187
• Product Code: OHA
• UDI-Device Identifier: 00877234000447
• UDI-Public: 00877234000447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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 Lot Number: UNKNOWN
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown