MAUDE Adverse Event Report: ARTIVION, 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 07/05/2023

Event Type  Injury  

Event Description

Implant summary card (isc) received back from the user facility (uf) notating previously implanted "cryolife" tissue was explanted (b)(6) 2023.According to the tissue database this patient had sgpv00 sid (b)(6) implanted (b)(6) 2015.This tissue was replaced with sgpv00 sid (b)(6).This investigation is relegated to sgpv00 sid (b)(6) donor number (b)(6).According to additional information, "it looks like this patient came in with infective endocarditis and had strep mitis.He had also outgrown his homograft and there was mass grown on the pulmonary valve.".

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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Manufacturer Narrative

An implant summary card (isc) was received 14aug2023 from the user facility (uf) notating previously implanted "cryolife" tissue was explanted (b)(6) 2023.According to the tissue database this patient had sgpv00 sid (b)(6) implanted (b)(6) 2015.This tissue was replaced with sgpv00 sid (b)(6).This investigation is relegated to sgpv00 sid (b)(6).According to additional information, "it looks like this patient came in with infective endocarditis and had strep mitis.He had also outgrown his homograft and there was mass grown on the pulmonary valve." a review of the information was performed and it was confirmed that all records were controlled, available for review, and met all specifications.The certificate of assurance for pulmonary valve & conduit sg (sgpv00) sid# (b)(6) was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.There are no rejectable attributes.During the final inspection of this graft, 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.A review of the available information was performed.Approximately 8 years post-operative the patient presented with described ¿infective endocarditis¿ and the patient had also outgrown the homograft.As a result, it was explanted on (b)(6) 2023; a significant time gap is noted between implant and the described clinical event.Another sgpv00 (pulmonary valve & conduit sg) was implanted during this same procedure.The cardiac instructions for use (ifu) lists endocarditis and normal valve outgrowth as a potential complication which have been reported with the use of cardiac allografts and should be considered when selecting the optimal valve replacement for each recipient.The surgeon indicated that the patient had ¿outgrown the valve¿ and given the time frame from a 10-to 18-year-old male, normal valve outgrowth is one of the underlying reasons for the explant.The cause for the reported vegetation and pathology remains unknown.However, given the postoperative period of approximately 8 years, there is no evidence to suggest that the reported endocarditis is associated with the allograft/donor.Patient has outgrown the valve and endocarditis both of which are known outcomes that are listed in the ifu.A complaint and recall query was performed for sgpv00 sid (b)(6) to identify previously reported complaints or recalls associated with this serial identification number.No complaints or recalls were identified for this serial identification number.Based on the available information, the cause for the reported vegetation and pathology remains unknown.However, given the postoperative period of approximately 8 years, there is no evidence to suggest that the reported endocarditis is associated with the allograft/donor.Patient has outgrown the valve and endocarditis both of which are known outcomes that are listed in the ifu.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.The processing records were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications.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.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion 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 ¿ formerly cryolife/jotec.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17715087
• MDR Text Key: 323008513
• Report Number: 1063481-2023-00018
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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: 133097
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male