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

Model Number PV10

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

Patient Problem Insufficient Information (4580)

Event Date 11/21/2022

Event Type  Injury  

Event Description

According to the implant summary card for sgpv00, sid (b)(6), yes and total were marked for the question "was previously implanted cryolife tissue explanted during this procedure?" based on a search in the implant summary database, this patient had pv10, sid (b)(6) from donor (b)(4) implanted on (b)(6) 2004.

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 for sgpv00, sid (b)(4), yes and total were marked for the question "was previously implanted cryolife tissue explanted during this procedure?" based on a search in the implant summary database, this patient had pv10, sid (b)(4) from donor (b)(6) implanted on (b)(6) 2004.

Manufacturer Narrative

Multiple attempts to obtain additional information were made.No additional information is forthcoming.There is limited information available regarding the event, including but not limited to preoperative diagnoses, past medical history, or the reason for the reported explant 18 years post-operative.No operative notes are available at this time and no explanted tissue was returned for evaluation.Per the implant summary database, this pv10 was implanted on (b)(6) 2004 in a 25-year-old female as a pulmonary valve.Per the implant card received, this valve was explanted on (b)(6) 2022 and a sgpv00 was implanted during the same procedure.There are no additional details available for the time frame between the original implant in 2004 and the procedure performed in 2022.There is insufficient information to determine a root cause for the reported explant.However, it was originally implanted as a pulmonary valve, so an explant occurring 18 years after implant demonstrates the homograft performed within expectations.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: 16335643
• MDR Text Key: 309156302
• Report Number: 3001451326-2023-00002
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PV10
• Device Lot Number: 44919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2023
• Date Manufacturer Received: 01/10/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female