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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
"pulmonary valve with conduit (sgpv00 ) ¿ 27 mm x 3. 5 cm - serial id (b)(4), exp. Date: july 9,2020, sized and measured @ 22 mm ¿ (using a hegar dilator ) and sized / measured @ 22 mm / tight 23 mm (using an sjm valve sizer) instead of the stated size 27 mm" pulmonary valve was saved and will be returned. Surgery was prolonged as a synthetic graft was used instead. The returned specimen was evaluated. Tissue size was tested with a size 28 mm dilator and was determined to be a good fit for the valve. Next size test was performed with a size 22 mm dilator that provided a clear view into the conduit and was determined to be too small for the valve. The following size test was performed with a size 26 mm dilator, providing a view into the conduit and determined to be too small for the valve. A 27 mm dilator was used on the final size test and was determined to be an appropriate size for the valve. Upon further examination, the 22 mm dilator was used inspect the size of tissue conduit and provided an accurate measure. No damage was noted and tissue texture was smooth.
 
Manufacturer Narrative
Data in is this a single use device that was reprocessed and reused on a patient? has been corrected to "no" this is not a single-use device that was reprocessed and reused on a patient. This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
"pulmonary valve with conduit (sgpv00 ) ¿ 27 mm x 3. 5 cm - serial id #10701257 exp. Date: july 9,2020 sized and measured @ 22 mm ¿ (using a hegar dilator ) and sized / measured @ 22 mm / tight 23 mm (using an sjm valve sizer) instead of the stated size 27 mm" pulmonary valve was saved and will be returned. Surgery was prolonged as a synthetic graft was used instead. The returned specimen was evaluated. Tissue size was tested with a size 28 mm dilator and was determined to be a good fit for the valve. Next size test was performed with a size 22 mm dilator that provided a clear view into the conduit and was determined to be too small for the valve. The following size test was performed with a size 26 mm dilator, providing a view into the conduit and determined to be too small for the valve. A 27 mm dilator was used on the final size test and was determined to be an appropriate size for the valve. Upon further examination, the 22 mm dilator was used inspect the size of tissue conduit and provided an accurate measure. No damage was noted and tissue texture was smooth.
 
Manufacturer Narrative
The sample was evaluated on 02/10/2017. Tissue size tested with a size 28 mm dilator and was determined to be a good fit for the basal ring. Next size test was performed with a size 22 mm dilator that provided a clear view past the basal ring into the conduit and was determined to be too small. The next size test was performed with a size 26 mm dilator, providing a view past the basal ring into the conduit and determined to be too small as well. A 27 mm dilator was used on the final size test and was determined to be an appropriate size for the basal ring as well. Upon further examination, the 22 mm dilator was used inspect the size of tissue conduit and provided an accurate measure of the conduit and not of the basal ring. No damage was noted and tissue texture was smooth. The inspector's training records and sizing certifications were reviewed. The inspector was certified to size cardiac tissues prior to performing inspection on 06/15/2015 and following inspection on 08/07/2015.  the certificate of assurance was reviewed. All attributes identified  were documented appropriately, including the graft size. It was confirmed that the dilators documented at inspection correlate to the graft size and all were within calibration at the time of inspection. While a definitive root cause is unknown, the size discrepancy noted by the complainant may be due to the difference in sizing technique. Information regarding the surgeon¿s method is unknown. No further action necessary. This event does not identify additional hazards or modify the probability and severity of existing hazards.
 
Event Description
"pulmonary valve with conduit (sgpv00 ) ¿ 27 mm x 3. 5 cm - serial id (b)(4) exp. Date: july 9,2020 sized and measured @ 22 mm ¿ (using a hegar dilator ) and sized / measured @ 22 mm / tight 23 mm (using an sjm valve sizer) instead of the stated size 27 mm" pulmonary valve was saved and will be returned. Surgery was prolonged as a synthetic graft was used instead.
 
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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 Key6364898
MDR Text Key68559175
Report Number1063481-2017-00007
Device Sequence Number1
Product Code OHA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/09/2020
Device Model NumberSGPV00
Device Lot Number134231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/02/2017
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2015
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: 02/28/2017 Patient Sequence Number: 1
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