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 08/09/2022

Event Type  Injury  

Event Description

According to the initial report, this patient was presented with endocarditis approximately two months after implant.

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

Multiple attempts to obtain additional information were made with no response.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.The cardiac ifu lists endocarditis and microbial infection as a potential complication and should be considered in the decision of graft selection.Given the limited amount of information available, the source of the reported endocarditis cannot be determined.There is insufficient information to determine the root cause for the reported endocarditis or any relation to the allograft/donor.Adequate precautions are provided in the instructions for use.The viable grafts processed for this donor were found to have acceptable microbiological results and were approved for release.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.As such, no further action is required at this time.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: 15374820
• MDR Text Key: 299450684
• Report Number: 1063481-2022-00018
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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: 159868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/09/2022
• Date Manufacturer Received: 08/09/2022
• 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): Other
• Patient Age: 16 YR
• Patient Sex: Male