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

Model Number PV00

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

Patient Problem Endocarditis (1834)

Event Date 06/02/2023

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 is accurate or has been confirmed by artivion.

Event Description

An implant summary card (isc) was received which indicated there was an explant of cryolife tissue during the implant of (sgpv00) serial number (sn) (b)(6).One previous implant was identified for this patient: pv00 serial number (b)(6), donor number (b)(6), implanted on (b)(6).10/27/2023: email from rep: "here is the response from the surgeon.Patient had severe pulmonary valve insufficiency from endocarditis of his conduit." no additional information withcoming.

Manufacturer Narrative

An implant summary card (isc) was received which indicated there was an explant of cryolife tissue during the implant of (sgpv00) serial number (sn) (b)(6) on (b)(6) 2023.One previous implant was identified for this patient: pv00 serial number (b)(6), donor number (b)(6), implanted on (b)(6) 2002.10/27/2023: email from rep: "here is the response from the surgeon.Patient had severe pulmonary valve insufficiency from endocarditis of his conduit." no additional information forthcoming.This complaint is associated with pv00, serial number (b)(6), donor number (b)(6).A review of the available information was performed.The certificate of assurance for pulmonary valve & conduit (pv00) 7165365 was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.No rejectable attributes were noted.Based on the performance of the tissue, there is no indication that there was any deficiency in the valve.During the inspection of each graft, a qualified inspector wearing surgical loupes inspects the graft noting any attributes.Based on a review of archived training records, the inspector was found to be appropriately trained at the time the task was performed.No findings were identified that could have contributed to the reported event.No further action is needed.An implant summary card (isc) was received which indicated there was an explant of cryolife tissue during the implant of (sgpv00) serial number (sn) (b)(6) on (b)(6) 2023.One previous implant was identified for this patient: pv00 serial number (b)(6), donor number (b)(6), implanted on (b)(6) 2002.10/27/2023: email from rep: "here is the response from the surgeon.Patient had severe pulmonary valve insufficiency from endocarditis of his conduit." no additional infomation forthcoming.This complaint is assoicated with pv00, serial number (b)(6), donor number (b)(6).Per the implant summary database, the homograft associated with this file was implanted into a 12.9-year-old male on (b)(6) 2002 and explanted approximately 20 years postoperative and replaced with another homograft on (b)(6) 2023.The database indicates the pv00 was implanted as a patch, but the location and type of procedure remains unknown.The information provided above states the explant was due to ¿severe pulmonary valve insufficiency from endocarditis of the conduit¿.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.The explanted tissue was not returned to artivion, and therefore could not be examined.Additionally, and no microbiology or pathology reports are available at this time related to the reported endocarditis as no additional information is forthcoming.The cardiac ifu states valvular and perivalvular insufficiency and endocarditis have 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 20 years post-operative.The report of endocarditis over 20 years after implant makes an allograft/donor derived infection unlikely.Adequate precautions are provided in the instructions for use.Explant of a cardiac homograft after 20 years not unexpected.This event was reviewed to construct a risk report.The explanted tissue was not returned to artivion.The serial number ((b)(6)) was received and no findings were found in the investigation.There is insufficient information to determine a root cause of the reported explant 20 years postoperative.The report of endocarditis over 20 years after implant makes an allograft/donor derived infection unlikely.Adequate precautions are provided in the instructions for use.Explant of a cardiac homograft after 20 years is not unexpected.The reported event will continue to be monitored for trends.Risk has been reduced as low as possible and overall residual risk is acceptable.A possible root cause is ¿severe pulmonary valve insufficiency from endocarditis of the conduit¿.The report of endocarditis over 20 years after implant makes an allograft/donor derived infection unlikely.There is no indication that an error or deficiency occurred at artivion formerly cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable; field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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): ARTIVON, INC.; 1655 roberts boulevard 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: 18022900
• MDR Text Key: 326796854
• Report Number: 1063481-2023-00019
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2011
• Device Model Number: PV00
• Device Lot Number: 55492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2001
• 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; Life Threatening; Other
• Patient Age: 33 YR
• Patient Sex: Male