MAUDE Adverse Event Report: CRYOLIFE, INC. PULMONARY VALVE & CONDUIT SG; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT

Model Number SGPV00

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congenital Defect/Deformity (1782); Pulmonary Valve Stenosis (2024)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(4) was implanted on (b)(6) 2015.Additional information from karen krusinski, rn cardiac or team leader, relayed that the sgpv00 serial number (b)(4) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.No additional information.

Event Description

According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(6) was implanted on (b)(6) 2015.Additional information from the rn cardiac or team leader, relayed that the sgpv00 serial number (b)(6) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.No additional information.

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 cryolife is accurate or has been confirmed by cryolife.

Manufacturer Narrative

A root cause for the reported event is conduit stenosis.This is a known potential complication in children undergoing the yasui procedure previously reported in the literature.There is no evidence to suggest that there was an inherent defect in the graft prior to implant.All attributes noted during inspection of the allograft were documented appropriately and the allograft met specifications.A review of training records indicates that the technicians associated with the processing of this allograft were appropriately trained for the tasks performed.There is no indication that an error or deficiency occurred at cryolife 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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(4) was implanted on (b)(6) 2015.Additional information from (b)(6), rn cardiac or team leader, relayed that the sgpv00 serial number (b)(4) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8463775
• MDR Text Key: 140283929
• Report Number: 1063481-2019-00016
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• PMA/PMN Number: K092021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/12/2019
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 129480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR