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U.S. Department of Health and Human Services

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

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CRYOLIFE, INC. PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT Back to Search Results
Model Number SGPV00
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
An email was received containing the following information: "cvor [cardio vascular operating room] coordinator mentioned that they had explanted an allograft pulmonary valve approx. 4 years after initial implant by [the surgeon]. Surgeon felt that this was earlier than expected failure of the valve. ".
 
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Brand NamePULMONARY VALVE & CONDUIT SG
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 Key6915358
MDR Text Key88255646
Report Number1063481-2017-00034
Device Sequence Number1
Product Code OHA
Combination Product (y/n)N
PMA/PMN Number
K092021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2016
Device Model NumberSGPV00
Device Catalogue NumberSGPV00
Device Lot Number113841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/08/2017
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2011
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: 10/05/2017 Patient Sequence Number: 1
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