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

Model Number SGPV00

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

Patient Problem Insufficient Information (4580)

Event Date 04/14/2023

Event Type  Injury  

Event Description

According to the implant summary card received, it was indicated that an explant of a previously implanted graft was performed.

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.

Event Description

According to the implant summary card received, it was indicated that an explant of a previously implanted graft was performed.

Manufacturer Narrative

The certificate of assurance for pulmonary valve & conduit sg (sgpv00) 11168788 was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.Per the implant summary database, the homograft associated with this file was implanted into a 13 day-old male on (b)(6) 2022 and explanted approximately 9 months postoperative and replaced with another patch homograft on (b)(6) 2023.Per the database, the homograft was used as a conduit only, patch and the reason for the explant is unknown currently.No additional information forthcoming.There is limited information available regarding the event, including but not limited to patient demographics, preoperative diagnoses, past medical history, indication for surgery, or the reason for the reported explant 9 months post-operative.The explanted tissue was not returned to artivion, and therefore could not be examined.The cardiac ifu states normal valve outgrowth has been reported with the use of cardiac allografts.No tissue sample was returned for evaluation and there is insufficient information to determine a root cause of the reported explant 9 months post-operative.Adequate precautions are provided in the instructions for use.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
• 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: 17236401
• MDR Text Key: 318179453
• Report Number: 3001451326-2023-00004
• Device Sequence Number: 1
• Product Code: MIE
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/07/2022
• Device Model Number: SGPV00
• Device Lot Number: 144445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2017
• 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: 9 MO
• Patient Sex: Male