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

Model Number SGPV00

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

Patient Problems Pulmonary Dysfunction (2019); Sudden Cardiac Death (2510)

Event Date 11/03/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to initial reports, cryolife sgpv00, serial number: (b)(4) was implanted on (b)(6) 2018 as an rv to pa conduit.The patient passed away on (b)(6) 2018 due to cardiac failure.

Manufacturer Narrative

The processing records for sgpv00, serial number (b)(4) were reviewed and it was determined that all attributes identified were documented appropriately and the allograft met specifications.The previous sano shunt was removed and replaced with an sgpv sano shunt.The patient¿s medical history contained acute heart failure, aortic stenosis, cyanosis, double outlet right ventricle; truncus arteriosus type 4, dysplastic aortic valve, left coronary artery stenosis, patent ductus arteriosus, pulmonary atresia, and ventricular septal defect.The use of valved homografts as rv-pa conduits in stage i of the modified norwood procedure has been described in literature and has increased in popularity over the bt shunt due to improved outcomes relating to increased postoperative hemodynamic stability (reinhartz 2006, shinkawa 2015, christenson 2010).The patient¿s history of severe congenital heart disease, abnormal cardiac anatomy, and failed sano shunt were likely contributing factors to the reported cause of death as cardiac failure.There is no indication that an error or deficiency occurred at cryolife.The risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to initial reports, cryolife sgpv00 serial number: (b)(4) was implanted on (b)(6) 2018 as an rv to pa conduit.The patient passed away on (b)(6) 2018 due to cardiac failure.No additional information.

• 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
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 8272100
• MDR Text Key: 133904117
• Report Number: 1063481-2019-00003
• Device Sequence Number: 1
• Product Code: OHA
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 146707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/28/2018
• Date Manufacturer Received: 12/28/2018
• 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): Death