MAUDE Adverse Event Report: ARTIVION, INC. AORTIC VALVE/CONDUIT W/O AML; HEART-VALVE, ALLOGRAFT

Model Number AV40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

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.

Event Description

According to the initial report received, patient who underwent aortic valve replacement on (b)(6) 1998 is now presenting with structural valve deterioration and will need reoperation.

Manufacturer Narrative

The certificate of assurance for aortic valve + conduit w/o aml was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.There are no rejectable attributes.No graft specific ncs were identified for this tissue.Per the information received, it was noted ¿not a complaint.From [nurse practitioner]¿was impressed by 25 years of excellent durability.Wanted to know valve size.¿ a potential redo not yet scheduled.Further information is currently not available regarding the implant details or patient medical or surgical history.Additionally, there are no additional details available for the time frame between the original implant in 1998 and now.Per our database, this allograft was implanted in a 44-year-old female on (b)(6) 1998 as an aortic valve.The allograft implanted was an aortic valve and conduit without aml.Dimensions noted to be 19mm x 4.4cm.As of this notification the valve is still implanted, as such, no tissue was returned and no evaluation can be performed at this time.The patient may need to undergo an additional surgical procedure, as the valve is now presenting with structural valve deterioration.The standard cryopreserved human tissue a/dfmea and pfmea were reviewed.The reported event is addressed.No tissue was returned for evaluation.There is insufficient information to determine a root cause for the reported structural valve deterioration.However, occurring at 25 years post- implant, the graft can be considered to have performed within expectations.Adequate precautions are provided in the instructions for use.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.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.

• Brand Name: AORTIC VALVE/CONDUIT W/O AML
• Type of Device: HEART-VALVE, 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: 16585118
• MDR Text Key: 311710632
• Report Number: 3001451326-2023-00003
• Device Sequence Number: 1
• Product Code: MIE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AV40
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/1997
• 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: 68 YR
• Patient Sex: Female