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

Model Number SGPV00

Device Problem Restricted Flow rate (1248)

Patient Problem Valvular Stenosis (2697)

Event Date 01/13/2020

Event Type  Injury  

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 previously implanted cryolife tissue was explanted on (b)(6) 2020.A query of the database revealed that sgpv00 serial number: (b)(4) was implanted on (b)(6)2012.Additional information received relayed per the surgeon "this patient did well.The sg pv was replaced due to stenosis-actually the patient had another manufacturer's valve implanted into it early-within one year of original implantation due to stenosis- an unusual case of early failure on my opinion.We replaced it with another sg pv conduit, adult sized.Both of these were used as rv-pa conduits.The 2012 was when the patient was young for a rv-pa conduit but now is adult sized.".

Manufacturer Narrative

The sgpv00 was implanted into a 6.63 year old male patient on (b)(6) 2020 as a right ventricle to pulmonary artery conduit.The sgpv00 was explanted after 7.12 years on (b)(6) 2020 when the patient was 13.75 years of age.The explanted sgpv00 was replaced with a new sgpv-- that was also used as an rv-pa conduit.The explanted sgpv00 was not returned for evaluation/analysis.There is very limited information available regarding details of this event, including patient demographics, preoperative and post-operative diagnoses, operative procedures performed at time of initial sgpv00 implant, melody valve implant, and sgpv00 explant, additional past medical history, definitive diagnosis of conduit stenosis that lead to sgpv00 explant.In addition, there are no clinic notes or operative procedure notes available for the initial sgpv00 implant, melody valve implant, or sgpv00 explant.The initial sgpv00 diameter measured 18mm while the replacement sgpv00 measures 25mm.The surgeon noted that the patient "was young for a rv-pa conduit but is now adult sized" suggesting that the patient outgrew the previous sgpv00 due to somatic outgrowth.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; rodenfeld 2008).Homografts have been reported as the gold-standard and conduit of choice for use in rvot reconstruction due to 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 most commonly used materials for pediatric congenita rvot procedures, despite the likely need for future reoperation, especially when used in pediatric patient (bielefeld 2001, brown 2005, kalfa 2012, rodefeld 2008).Risk factors for rv-pa conduit stenosis and insufficiency have been reported in the literature.Young patient age at time of implant (brown 2005, karamlou 2006, poynter 2013) has been associated with accelerated risk of deterioration and replacement of allograft rvot conduits, especially in neonates and small children (karamlou 2006, poynter 2013, brown 2005).Other risk factors include small conduit diameter (<22 mm ¿ kalfa 2012), use in non-ross rvot procedures (bielefeld 2001; brown 2005; kalfa 2012; rodefeld 2008), and use aortic allografts (karamlou 2006, niwaya 1999) have also been reported.Niwaya et al.Identified use of aortic allografts as rv-pa conduits to be associated with homograft dysfunction (niwaya 1999).Karamlou et al.Reported similar findings, as patients having aortic allografts demonstrated early development of conduit stenosis and had more rapid gradient progression (p<.001) than did patients with all other conduit types (karamlou 2006).Explant of an sgpv used as an rv-pa conduit after approximately 7 years in a patient that was 6.6 years of age at time of implant is not unexpected.Valvular and conduit stenosis, graft failure, and normal outgrowth are known potential adverse events associated with the use of cardiac allografts and are listed in the sgpv instructions for use (cryovalve sg ifu).Conduit stenosis, normal valve outgrowth, and structural valve deterioration of an sgpv00 used as an rv-pa conduit after over 7 years in a pediatric patient that was 6.6 years of age at time of implant in not unexpected.The root cause of the reported event is most likely due to somatic outgrowth.Adequate precautions regarding risk of graft stenosis and normal valve outgrowth are provided in the instructions for use.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.

Event Description

According to the initial report previously implanted cryolife tissue was explanted on (b)(6) 2020.A query of the database revealed that sgpv00 serial number: (b)(4) was implanted on (b)(6) 2012.Additional information received relayed per the surgeon "this patient did well.The sg pv was replaced due to stenosis-actually the patient had another manufacturer's valve implanted into it early-within one year of original implantation due to stenosis- an unusual case of early failure on my opinion.We replaced it with another sg pv conduit, adult sized.Both of these were used as rv-pa conduits.The 2012 was when the patient was young for a rv-pa conduit but now is adult sized.".

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE INC.; 1655 roberts blvd.; kennesaw GA 30144
• MDR Report Key: 9727604
• MDR Text Key: 190612655
• Report Number: 1063481-2020-00084
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• PMA/PMN Number: K092021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/25/2017
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 119214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 13 YR