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 11/21/2022

Event Type  Injury  

Event Description

According to the initial report, this graft was explanted due to endocarditis.This graft was implanted on (b)(6) 2021 and explanted on (b)(6) 2022.No adverse patient effects were reported.

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.

Manufacturer Narrative

No additional information will be forthcoming as patient has denied consent to release information to artivion.According to the reported information the allograft was implanted into a 41-year-old male on (b)(6) 2021 as a pulmonary valve per the implant summary card.Details related to this implant procedure are unavailable at this time.Per the additional information received, this original valve was explanted on (b)(6) 2022, approximately 12 months post-operative due to endocarditis, hence a significant time gap is noted between implant and the described clinical event.A sgpv00 (pulmonary valve & conduit sg) was implanted during this same procedure.The file for this donor was reviewed and met all criteria for allograft processing as well as medical director review.Therefore, the donor was found to be eligible for donation, and the tissue was released per all processing criteria.No tissue was returned for evaluation and no laboratory or pathology reports have been provided to confirm the reported endocarditis.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.The cardiac ifu lists endocarditis as a potential complication and should be considered in the decision of graft selection.There is insufficient information to determine the root cause for the reported events and any relation to the allograft/donor.There is no evidence to suggest that the reported endocarditis is associated with the allograft related to this procedure/patient.Adequate precautions are provided in the instructions for use.Additionally, the explanted tissue was not returned to artivion, and therefore could not be examined to determine a root cause for the reported endocarditis.Given that all microbiological testing performed by artivion during processing produced acceptable results, the reported event most likely represents a contamination occurring at the implanting site.The current controls in place adequately mitigate risk to the patient.Risk has been reduced as low as possible and overall residual risk is acceptable.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
• Type of Device: 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: 16400499
• MDR Text Key: 309898888
• Report Number: 1063481-2023-00003
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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 Catalogue Number: SGPV00
• Device Lot Number: 166433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/19/2023
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male