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

Model Number SGPV00

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the report, "during the case on (b)(6), [the surgeon] was forced to downsize a pulmonary valve.The valve spec sheet stated that it was 20mm but the surgeon felt that the valve was quite a bit larger, possibly as large as 26mm.The valve was down sized and implanted with a good outcome." or operative time was extended.

Manufacturer Narrative

According to the report, "during the case on (b)(6), [the surgeon] was forced to downsize a pulmonary valve.The valve spec sheet stated that it was 20mm but the surgeon felt that the valve was quite a bit larger, possibly as large as 26mm.The valve was down sized and implanted with a good outcome." or operative time was extended.Multiple attempts were made to determine the method by which the surgeon measured the valve; however, all attempts were unsuccessful.A review was performed of the available information.The synergraft pulmonary valve was not returned to cryolife so no direct observations could be made.The valve diameter is determined when a dilator is placed at the level of the basal ring until the dilator fully occupies the valve orifice without distention.The allograft measurements listed on the certificate of assurance reflect the final lab measurements determined at inspection.This allograft size met specification.A review of training records indicates that the technicians who handled this allograft were appropriately trained for the task they performed.The root cause for the reported event is unknown.

Event Description

According to the report, "during the case on (b)(6), [the surgeon] was forced to downsize a pulmonary valve.The valve spec sheet stated that it was 20mm but the surgeon felt that the valve was quite a bit larger, possibly as large as 26mm.The valve was down sized and implanted with a good outcome." or operative time was extended.

• Brand Name: CRYOVALVE SG - PULMONARY VALVE AND 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: 5483780
• MDR Text Key: 40079836
• Report Number: 1063481-2016-00033
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/04/2020
• Device Model Number: SGPV00
• Device Lot Number: DONOR 133806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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