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The certificate of assurance for pulmonary valve & conduit sg (b)(6) was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.There are no rejectable attributes per qs3085 ¿ pulmonary valved ¿ sg allograft attributes.No graft specific ncs were identified for this tissue.No findings were identified that could have contributed to the reported event.No further action is needed.Graft (b)(6) was not returned to cryolife so no direct observations could be made.During the inspection of each cardiac graft, a qualified inspector wearing surgical loupes inspects the graft noting any attributes such as holes, tears, disruptions, plaque, etc.According to the processing records, this graft did not contain any attributes that would have rejected the graft.A review of training records indicates that the technician who inspected this graft was appropriately trained at the time the task was performed.According to the implant summary card received via email on 16-sept-2020 from s.P., cryolife administrative assistant, the implant summary card is marked indicating that cryolife tissue was explanted from the patient on (b)(6) 2020.A search of the cryolife implant database produced sgpv00 (pulmonary valve & conduit sg, sgpv) serial number (sn): (b)(6), donor number: (b)(6) that was implanted in the patient on (b)(6) 2003.No product will be returned for evaluation.Additional information received from m.W., cryolife representative, sgpv00 sn:(b)(6) was explanted from the patient on (b)(6) 2020.This valve was explanted to complete the repair of the rv-pa conduit.The valve was implanted back in 2003 due to the patient being diagnosed with tetrology of fallot with pulmonary atresia.Operative notes are not available.The patient is out of the hospital.There is limited information available regarding the event, including but not limited to patient demographics, preoperative diagnoses, past medical history, etc.According to our implant database, the explanted tissue, sgpv00 sn: (b)(6), was implanted on (b)(6) 2003 into a 9-month-old male.The dimensions of this valve on record are for a pulmonary valve sg 14mmx2.2cm at the time of implant for treatment of tetrology of fallot with pulmonary atresia (as supplied above).Per the implant card received for sid (b)(6), this original valve was explanted on (b)(6) 2020, approximately 17 years post-operative.Currently the patient is approximately 18 years old.The dimensions of the sgpv implanted are documented to be 26mm x 4.0cm.The use of cryopreserved allografts for right ventricular outflow tract (rvot) reconstruction in pediatric patients has been widely reported in the literature (bielefeld 2001; brown 2005; kalfa 2012; rodefeld 2008).Homografts have been reported as the gold-standard and conduit of choice for use in rvot reconstruction due to the excellent hemodynamics, resistance to infection, lack of need for anticoagulation, ease of handling, and decreased thromboembolic events (bielefeld 2001; kalfa 2012).Homografts remain one of the most commonly used materials for pediatric rvot procedures, despite the likely need for future reoperation, especially when used in neonates and infants <2 years of age (bielefeld 2001, brown 2005, kalfa 2012, rodefeld 2008).The diagnosis for the explant is currently unavailable.Explant of a 14mm sgpv used as an rv to pa conduit after more than 17 years in a pediatric patient is not unexpected.Normal valve outgrowth has been reported or associated with the use of cryopreserved allografts and is included in the cryovalve sg instructions for use.The implant duration per the implant summary cards associated with this file was approximately 17 years.The reason for the explant is currently unknown but is not an unexpected event in a pediatric patient.In addition, the explanted tissue was not returned to cryolife, and therefore could not be examined.The root cause of the reported explant is most likely normal valve outgrowth and adequate precautions are provided in the instructions for use.The sg human tissue a/dfmea was reviewed.The reported event is addressed in hazard step/item #: 88.The sg cryopreserved human tissue pfmea was reviewed.The instructions for use ifu l1153 were reviewed and are found to be adequate.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.The root cause of the reported event is most likely due to normal valve outgrowth.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.This report is being submitted as required by federal 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.
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