PULMONARY VALVE & CONDUIT SG SGPV00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-27 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..

Event Text Entries

[112493905] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10


[112493906] According to the report, the patient received the sgpv00 on (b)(6) 2017. The patient's 6-month post-operative scan indicated pulmonary valve conduit stenosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1063481-2018-00022
MDR Report Key7642466
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-06-27
Date of Report2018-09-19
Date Facility Aware2018-06-04
Date Mfgr Received2018-06-04
Date Added to Maude2018-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePULMONARY VALVE & CONDUIT SG
Generic NameHEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
Product CodeOHA
Date Received2018-06-27
Model NumberSGPV00
Catalog NumberSGPV00
Lot Number143283
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC.
Manufacturer Address1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2018-06-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.