MAUDE Adverse Event Report: ARTIVION, INC. PULMONARY VALVE & CONDUIT; HEART-VALVE, ALLOGRAFT

Model Number PV00

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

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/09/2023

Event Type  Injury  

Event Description

According to the report, a pulmonary valve implanted on (b)(6) 2001 was explanted on (b)(6) 2023 due to calcification.

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.

Manufacturer Narrative

A sample evaluation was not performed as the graft was discarded at the user facility.The certificate of assurance was reviewed.All attributes identified during inspection were documented appropriately.There are no rejectable attributes.No graft specific ncs were identified for this tissue.The inspector was a former employee who no longer works at artivion.Training records available to be reviewed along with the extended performance of the graft indicate that there was no deficiency in the valve and the inspector was appropriately trained.There is limited information available regarding the event, including but not limited to preoperative diagnoses or past medical history.No operative notes are available at this time and no explanted tissue was returned for evaluation.Per the implant summary database, this pv00 was implanted on (b)(6) 2001 in a 24-year-old male as a pulmonary valve.Per the implant card received, this valve was explanted 22 years later due to calcification on (b)(6) 2023; a sgpv00 was implanted during the same procedure.There are no additional details available for the time frame between the original implant in 2001 and the procedure performed in 2023.Per the information provided, the valve was explanted due to calcification.Calcification is a known outcome with the use of pulmonary homografts; adequate precautions are provided in the instructions for use.An explant occurring 22 years after implant is not uncommon and demonstrates the homograft performed within expectations.The standard cryopreserved human tissue a/dfmea and pfmea were reviewed.The reported event is addressed.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: PULMONARY VALVE & CONDUIT
• 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: 18703050
• MDR Text Key: 335358798
• Report Number: 1063481-2024-00002
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2009
• Device Model Number: PV00
• Device Lot Number: 43393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/1999
• 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: 46 YR
• Patient Sex: Male