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 Unspecified Heart Problem (4454)

Event Date 06/30/2022

Event Type  Injury  

Event Description

An implant summary card was received back from the user facility notating a previously implanted artivion tissue was explanted."previous ross procedure" was also written on the card.A query of the implant database found pv00, sid (b)(4) implanted (b)(6) 1995 for this patient.Date of explant (b)(6) 2022.The tissue was implanted for 27 years.No additional information forthcoming.This investigation is relegated to pv00, sid (b)(4).

Manufacturer Narrative

The certificate of assurance for pulmonary valve and conduit (b)(6) was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.No rejectable attributes were noted.No graft specific ncs were identified for this tissue.No findings were identified that could have contributed to the reported event.No further action is needed.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 27 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 pv00 was implanted on (b)(6) 1995 in a 40-year-old female for a ross procedure.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 1995 and the procedure performed in 2022.There is insufficient information to determine a root cause for the reported explant.However, it was originally implanted for a ross procedure so an explant occurring 27 years after implant demonstrates the homograft performed within expectations.Adequate precautions are provided in the instructions for use.The standard cryopreserved human tissue risk management file was reviewed.The reported event can be addressed.No tissue was returned for evaluation.There is insufficient information to determine a root cause for the reported explant.However, it was originally implanted for a ross procedure so an explant occurring 27 years after implant demonstrates the homograft 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.Based on the available information, the root cause is unknown.All attributes identified during inspection were documented appropriately on the certificate of assurance.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.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
• 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 boulevard nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15242751
• MDR Text Key: 298073724
• Report Number: 1063481-2022-00014
• Device Sequence Number: 1
• Product Code: MIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PV00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female