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

Model Number PV00

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

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  Injury  

Event Description

According to the initial report, this tissue was partially explanted on (b)(6) 2022.

Event Description

According to the initial report, this tissue was partially explanted on (b)(6) 2022.

• Brand Name: PULMONARY VALVE & CONDUIT
• Type of Device: HEART-VALVE, 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: 14018151
• MDR Text Key: 288652540
• Report Number: 1063481-2022-00004
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PV00
• Device Lot Number: 30983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2022
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male