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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. SYNERGRAFT PULMONARY VALVE AND CONDUIT HEART VALVE

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CRYOLIFE, INC. SYNERGRAFT PULMONARY VALVE AND CONDUIT HEART VALVE Back to Search Results
Model Number SGPV00
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 12/07/2016
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 email from the surgeon, "we had some cracks in the muscle of the homograft again but i was able to work around them ok. I didn't expect to do a ross because she has a bicuspid pulmonary valve but i couldn't re-repair her so i did it anyway. It worked very nicely. ".
 
Manufacturer Narrative
Attempts were made to obtain additional information including whether there was a delay in the procedure and whether the proper handling, storage, and thaw and rinse processes were performed. No further information was available. The cryolife representative was able to speak to the surgeon and stated "he tried to downplay the situation and felt like it was no big deal. It did not increase his surgery time. " a review was performed of the available information. The allograft was not returned so no direct observations could be made. A review of training records indicates that the technicians who handled this allograft while in the frozen state were appropriately trained for the tasks they performed. There are no allograft-specific non-conformances associated with this tissue. There are no non-conformances associated with the transfer or handling of this allograft. No deviations were identified during a review of the tissue transfer logs and the packaging inspection sheet. The allograft was shipped to (b)(6) med ctr via (b)(6) on 10/05/2016 for priority overnight. Prior to the shipment of this allograft, there were no abnormalities noted on the outer packaging. There were no incident reports filed in the courier database for (b)(6) during transit/delivery of this allograft. No findings were identified that could have contributed to the reported event. As the allograft was not returned for evaluation a definitive root cause cannot be determined; however, the issue noted by the complainant may have been caused by mishandling the packaged allograft while in the frozen state. The ifu provides the following instructions: "cryopreserved allografts are fragile and must be handled with care while in the frozen state to avoid causing damage to allograft or packaging," "valve may be damaged or the integrity of the pouch may be compromised if not properly handled. Do not implant the cryovalve sg:. If the package has been handled with sharp instruments, dropped while at cryogenic temperatures, or otherwise mishandled," and "the cardiac thawing and rinsing instructions must be followed exactly to minimize physical damage to the valve. " the unpacking instructions shipped with each allograft state: "if an allograft is to be stored in a low temperature storage freezer (at or below -135°c), locate an empty slot in the racking system that is not exposed to liquid nitrogen and carefully place the allograft into the empty slot. The allograft should remain in the cardboard box throughout the duration of the allograft's storage at the facility. " device remains implanted.
 
Event Description
According to the email from the surgeon, "we had some cracks in the muscle of the homograft again but i was able to work around them ok. I didn't expect to do a ross because she has a bicuspid pulmonary valve but i couldn't re-repair her so i did it anyway. It worked very nicely. ".
 
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Brand NameSYNERGRAFT PULMONARY VALVE AND CONDUIT
Type of DeviceHEART VALVE
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
MDR Report Key6228420
MDR Text Key64033471
Report Number1063481-2017-00001
Device Sequence Number1
Product Code OHA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/29/2020
Device Model NumberSGPV00
Device Lot Number136565
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/07/2016
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
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