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U.S. Department of Health and Human Services

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

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CRYOLIFE, INC. SG PULMONARY VALVE & CONDUIT HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT Back to Search Results
Model Number SGPV00
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
According to the report, ¿[doctor] reports that he did a ross procedure on a patient approximately 1 year ago and implanted [product]. The [product] has prematurely failed according to [doctor] and he plans to reoperate later this month to replace the failed [product]. [doctor] described the failure as being within the conduit and not at the valve annulus or pa. [doctor] believes the failure is due to some sort of an immunologic response to the transplant. The reoperation has yet to be scheduled however [doctor] intends to send the explanted [product] for evaluation. " correspondence was made to obtain pathology report and return sample. Report and sample was received leading to request for more information. This information was requested through multiple correspondences to no avail. The tissue sample is distal conduit. Doctor left the proximal conduit intact because he felt it was too close to the left main coronary artery. The doctor described the leaflets as being normal but the conduit as being "destroyed" and narrowed from an originally implanted 18mm down to an 8mm size equivalent. He replaced the valve. " the patient is a (b)(6) year old male patient underwent implantation to replace the patient¿s native pulmonary valve during a ross procedure on (b)(6) 2016. Approximately one year later ((b)(6) 2017), the patient required surgical intervention due to a ¿premature failure¿ of the valve. Per information provided by the implanting and explanting surgeon the ¿failure was believed to be an immunologic response to the implant of the valve. ¿ doctor described the failure as ¿being within the conduit and not at the valve annulus or pa¿ and ¿believes the failure is due to some sort of an immunologic response to the transplant. ¿ at time of explant, doctor left the proximal conduit intact ¿because he felt it was too close to the left main coronary artery¿ and described the leaflets as ¿being normal but the conduit as being 'destroyed' and narrowed from an originally implanted 18mm down to an 8mm size equivalent. ¿ the product was explanted on (b)(6) 2017 and replaced. The patient¿s preoperative diagnosis was noted on the surgical pathology request provided by the explant hospital as ¿congenital aortic stenosis¿. All other information regarding the patient¿s pertinent past medical history is unknown. The final pathological diagnosis from the hospital was, ¿dystrophic calcification, fibrosis, foreign body giant cells reaction and focal myxoid change. ¿ cryolife's pathology results note: ¿histologic sections show a band of poorly cellularized collagenous tissue histologically consistent with residual homograft conduit. There is fibrosis along the adventitial surface with scant mononuclear inflammatory cells. The intimal surface shows intimal proliferation with artefactual separation of the intima from the underlying conduit. There is a band of lymphocytes and plasma cells at the interface between the neointima and the subjacent conduit. Minimal focal foreign body inflammatory response is present around residual surface. ¿ the final diagnosis per cryolife's pathology report was, ¿acellular collagenous tissue histologically consistent with allograft conduit. Intimal hyperplasia with mild chronic inflammation at interface with conduit. Minimal foreign body reaction to sutures. ¿ the use of pulmonary allografts, including sgpv00, for replacement of the native pulmonary valve in the ross procedure has been widely reported in the literature (brown 2010, brown 2011, kalfa 2011). In addition, pulmonary allografts are considered the gold standard for rvot reconstruction in the ross procedure due to excellent hemodynamics, resistance to infection, lack of need for anticoagulation, ease of handling, option of using pulmonary artery branches, and decreased thromboembolic events (bielefeld 2001; kalfa 2012). Homografts remain one of most commonly used materials for pediatric rvot procedures, despite the likely need for future reoperation, especially when used in neonates and infants (brown 2005, kalfa 2012, rodefeld 2008). Risk factors for pulmonary homograft failure after the ross procedure have been discussed in the literature and include younger patient age and smaller conduit size (diameter <22 mm; kalfa 2011, charitos 2012, mokhles 2013). Limited information is available regarding preoperative patient medical history, operative notes, definition of "failure¿ according to the surgeon, previous reinterventions of the sgpv00 conduits, and history of events leading up to explant event. The surgeon alleged that the conduit had narrowed from an implant size of 18 mm to 8 mm at time of explant. The histopathologic findings of intimal hyperplasia and fibrosis suggest that the clinical stenosis/conduit failure was likely a result of intimal overgrowth within the conduit. Since only mild inflammation and preservation of normal leaflets was noted, the contribution of an underlying immunologic process remains unclear. A generalized immune mediated response, i. E. A rejection type response, would be expected to affect all areas of the allograft. The etiology of intimal hyperplasia and fibrosis is not completely understood, however, conduit stenosis of pulmonary allografts used in the ross procedure has been previously reported in the literature (mokhles 2013, carr-white 2001). Altered blood flow dynamics caused by conduit to pulmonary artery mismatch may be a possible contributing factor. Donor review revealed a (b)(6) year old female weighing (b)(6) pounds who passed due to asthma. The returned pulmonary sample was rigid in texture and there was evidence of non-manufacturer sutures present on the tissue. The sample only measured about 1cm and due to rigidity of the conduit it was difficult to visually determine any possible root cause. All attributes identified during inspection were documented appropriately. None of the identified attributes would have caused rejection of the graft. This report is being submitted as required by regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
Event Description
According to the initial report, "approximately one year ago, a patient implanted with sg pulmonary valve and conduit required surgical intervention due to a reported "premature failure"; the failure, reported from the surgeon, is believed to be an immunologic response to the implant of the valve.
 
Manufacturer Narrative
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
According to the initial report, "approximately one year ago, a patient implanted with  sg pulmonary valve and conduit required surgical intervention due to a reported "premature failure"; the failure, reported from the surgeon, is believed to be an immunologic response to the implant of the valve.
 
Manufacturer Narrative
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
 
Event Description
According to the initial report, "approximately (b)(6), a patient implanted with sg pulmonary valve and conduit required surgical intervention due to a reported "premature failure"; the failure, reported from the surgeon, is believed to be an immunologic response to the implant of the valve.
 
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Brand NameSG PULMONARY VALVE & 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 Key6597487
MDR Text Key204861745
Report Number1063481-2017-00018
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,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/23/2020
Device Model NumberSGPV00
Device Catalogue NumberSGPV00
Device Lot Number133999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/01/2017
Event Location No Information
Date Manufacturer Received05/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2015
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: 05/30/2017 Patient Sequence Number: 1
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