MAUDE Adverse Event Report: CRYOLIFE, INC. ALT PULMONARY VALVE + CONDUIT; HEART-VALVE, ALLOGRAFT

Model Number PV05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 05/27/2021

Event Type  Injury  

Event Description

According to the implant summary card returned from (b)(6), cryolife tissue was explanted from a patient on (b)(6) 2021.A query of the cryolife implant database revealed that a pv05 (alt pulmonary valve + conduit) was implanted in the patient on (b)(6) 1999 as a pulmonary valve.Additional information from the surgeon is as follows the patient is well.The pulmonary valve was explanted due to moderate pulmonary regurgitation and mild stenosis.The surgeon was impressed that the valve lasted 22 years.The request for operative notes and h&p were denied.The valve was not available for return to cryolife for evaluation.No additional information is forthcoming.

Event Description

According to the implant summary card returned from cedar sinai los angeles, cryolife tissue was explanted from a patient on (b)(6) 2021.A query of the cryolife implant database revealed that a pv05 (alt pulmonary valve + conduit) was implanted in the patient on (b)(6) 1999 as a pulmonary valve.Additional information from the surgeon is as follows the patient is well.The pulmonary valve was explanted due to moderate pulmonary regurgitation and mild stenosis.The surgeon was impressed that the valve lasted 22 years.The request for operative notes and h&p were denied.The valve was not available for return to cryolife for evaluation.No additional information is forthcoming.

• Brand Name: ALT PULMONARY VALVE + CONDUIT
• Type of Device: HEART-VALVE, ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 12370334
• MDR Text Key: 268243712
• Report Number: 3001451326-2021-00005
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PV05
• Device Lot Number: 31861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR