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U.S. Department of Health and Human Services

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

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CRYOLIFE, INC. CRYOVALVE SG PULMONARY VALVE AND CONDUIT HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT Back to Search Results
Model Number SGPV00
Device Problem Torn Material (3024)
Patient Problem No Code Available (3191)
Event Date 02/07/2017
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
"razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within a mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know. Have a great time away. " via doctor. (b)(6). Patient impact was listed as prolonged surgery.
 
Manufacturer Narrative
According to the doctor¿s notes received via email on (b)(6) 2017: "razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within an mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know. ¿  a review of training records indicates that the technician who inspected this allograft was appropriately trained for the task she performed. The inspector noted: one 6mm unrepaired tear in the muscle band 3mm from the lsc (left semilunar cusp) annulus. A donor review was also performed. According to the processing records, this allograft did not contain any attributes that would have rejected the allograft. Graft 10949532 was not returned to cryolife so no direct observations could be made. Pictures were provided from the hospital.   it is possible that the tear could have torn closer than 3mm with handling and pulling of the muscle band by the surgeon, as seen in pictures provided. The certificate of assurance was reviewed. All attributes identified  were documented appropriately. An acceptable tear was noted in that location, that met specifications. The root cause of the event is unknown; however, based on the information available the issue may have occurred while manipulating the tissue during the procedure as shown in the pictures provided.
 
Event Description
"razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within a mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know. Have a great time away. " via doctor. Sid is (b)(6). Patient impact was listed as prolonged surgery.
 
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Brand NameCRYOVALVE SG PULMONARY VALVE AND CONDUIT
Type of DeviceHEART 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
MDR Report Key6375721
MDR Text Key68976553
Report Number1063481-2017-00010
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSGPV00
Device Lot Number142199
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/07/2017
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/04/2016
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: 03/03/2017 Patient Sequence Number: 1
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