MAUDE Adverse Event Report: ARTIVION, 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	Pseudoaneurysm (2605)
Date of Event	11/05/2024
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 implant summary card received previously implanted artivion tissue was explanted from a patient on (b)(6) 2024.Artivion implant database revealed sgpv00 serial number: (b)(6) for this patient.This investigation is relegated to sgpv00 serial number: (b)(6) with allegation of explant due to repair of pseudoaneurysm.
Additional Manufacturer Narrative
The certificate of assurance for pulmonary valve & conduit sg (b)(4) was reviewed.All attributes identified during inspection were documented appropriately.There are no rejectable attributes per qs3001 ¿ cardiac allograft attributes.During the final inspection of this graft, per gp1350, sub-assembly, inspection; graft, cardiac and vascular, the dilator should fully occupy the valve orifice at the level of the basal ring and should fully engage the annular circumference at the basal ring and fit without distention.As part of inspection of the graft, the final label measurements are determined by the inspector.The inspector¿s training records were reviewed, and the technician was found to be appropriately trained at the time the task was performed.No findings were identified that could have contributed to the reported event.According to the artivion implant database, the explanted tissue, sgpv00 serial number: (b)(6) was implanted into a 12-year-old male on (b)(6) 2024.The implant summary card indicates that it was used as a ¿pulmonary valve¿; other details related to this implant procedure are unavailable at this time.Per the initial information received, the homograft was explanted on (b)(6) 2024, approximately 5 months post-operative due to pseudoaneurysm; the specific location (proximal or distal) remains unknown.Operative notes are not available for the incident or reoperation currently and no additional information is pending.No tissue was returned for evaluation, and no laboratory or pathology reports have been provided to lend more information related to the cause or extent of the reported pseudoaneurysm.Homografts remain one of the most used materials for pediatric cardiac reconstruction procedures, despite the likely need for future reoperation.Our labeling lists known adverse events, including pseudoaneurysm formation, related to the use of homografts; many of which may lead to the explant.Reoperation for pseudoaneurysm formation in this patient population is a known occurrence also described in the literature.(bielefeld 2001, brown 2005, kalfa 2012, rodefeld 2008, levine 1995).No tissue sample was returned for evaluation and there is insufficient information to determine a root cause of the reported pseudoaneurysm.Reoperation due to pseudoaneurysm in this pediatric population is not an unexpected outcome as reported in the literature.Adequate precautions are provided in our labeling.The synergraft cryopreserved human tissue a/dfmea was reviewed.The reported event is addressed in hazard step/item #s a.5 - 11a, 11b.The sg cryopreserved human tissue pfmea was reviewed.The reported tissue was not returned to for evaluation.A review of the tpl (tissue processing laboratory) report for sid# (b)(6) found no related issues.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.No tissue sample was returned for evaluation and there is insufficient information to determine a root cause of the reported pseudoaneurysm.Reoperation due to pseudoaneurysm in this pediatric population is not an unexpected outcome as reported in the literature.Adequate precautions are provided in our labeling.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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- formerly cryolife/jotec is accurate or has been confirmed by artivion.References: 1.Bielefeld et al.Annals of thoracic surgery 2001; 71(2): 482-8.2.Brown et al.Annals of thoracic surgery 2005; 80(2): 655-64.3.Kalfa et al.European journal of cardiothoracic surgery 2012; 42(6): 981-7.4.Rodefeld et al.The journal of heart valve disease 2008; 17(1): 119-26.5.Levine et al.Annals of thoracic surgery 1995; 59: 60-66.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Common Device Name: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 22967209
• Report Number: 1063481-2025-00076
• Device Sequence Number: 21084479
• Product Code: OHA
• UDI-Device Identifier: 00877234000447
• UDI-Public: 00877234000447
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K092021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (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): 11/21/2025

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: 176974
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male