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

Model Number SGPV00

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Insufficiency (2022)

Event Date 03/05/2020

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 initial reports, patient presents with severe pulmonary insufficiency, non-infectious.Patient had sgpv00 serial number (b)(4) implanted on (b)(6) 2018.The valve has not been explanted.

Manufacturer Narrative

According to additional information the 30mm sgpv was implanted in a 63.2-year-old male patient as a pulmonary valve during a ross procedure on 03/13/2018.On 03/06/2020, approximately 2 years post-operative, it was reported that the patient was exhibiting severe pulmonary insufficiency and ¿early signs of failure¿.As of 03/23/2020, a reoperation had not been scheduled and it was ¿still unsure when the surgeon will re-operate.¿ an increasing body of evidence suggests that the ross procedure is associated with better long-term outcomes compared with conventional aortic valve replacement in young and middle-aged adults (mazine 2018).Pulmonary homografts are considered the gold standard for reconstruction of the right ventricular outflow tract (rvot) in the ross procedure (brown 2011, mazine 2018).Pulmonary homograft dysfunction after the ross procedure has been reported in the literature (brown 2011, granados 2004, mazine 2018, tavakkol 2005, konuma 2009), manifesting predominantly as progressive valvular or supravalvular pulmonary stenosis, with pulmonary insufficiency, most commonly due to homograft leaflet prolapse, occurring to a lesser extent (mazine 2018, granados 2004).Multiple studies have compared outcomes for sgpv vs.Standard-processed (st) pulmonary homografts in adult patients undergoing the ross procedures.Brown et al.Reported outcomes for 193 sgpv vs.665 st ross patients and found that pulmonary insufficiency was significantly reduced in the sg vs.St groups (brown 2010).A later study by brown et al.Also compared outcomes for 63 ross patients (29 sgpv vs 34 st) (brown 2011).Median grade of conduit regurgitation progressed in both groups; median degree of insufficiency for the sgpv group was trivial in 15 and mild in 14 (median +2, range, 0 to +2) but was more for the standard group, with 10 trivial, 23 mild, and 1 moderate (median +2, range, 0 to +3; p = 0.10); none required reintervention.Freedom from moderate pulmonary conduit regurgitation was superior for the sgpv vs.St groups, with rates of 100% vs.98% at 3 years and 100% vs.94% at 9 years postoperative (brown 2011).Konuma et.Al reported similar outcomes in 71 ross patients, 41 sgpv vs.40 st (konuma 2009).The overall degree of insufficiency was higher in the standard allograft group (p = 0.07), and when analyzed for incidence of clinically important (>+3) insufficiency, a statistically significant advantage for the sgpv vs.St group (konuma 2009).Multivariate analysis revealed weight, graft size, and the presence of a previous conduit to be significant factors for the development of pulmonary insufficiency (konuma 2009).Mazine et al also reported pre-operative pulmonary hypertension¿especially when it is severe and/or irreversible¿ to be a risk factor for premature homograft degeneration (mazie 2018).Valvular and perivalvular insufficiency have been reported with the use of cryopreserved cardiac allografts and are included in the cryovalve sg pulmonary human heart valve instructions for use.Adequate precautions regarding the potential risks are included in the sgpv ifu.The root cause of the reported insufficiency is unknown.Valve insufficiency is a known potential complication of the ross procedure.Adequate precautions are provided in the allograft instructions for use.Per the review of the manufacturing records, all records were controlled, available for review, and met all specifications for release.There is no indication that an error or deficiency occurred and the ifu adequately communicates risk.All risks identified have been mitigated as far as possible and residual risk is acceptable.The 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.

Manufacturer Narrative

Correction to section e data removed based on failure message.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9814138
• MDR Text Key: 190619937
• Report Number: 1063481-2020-00001
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 134598
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/05/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 03/05/2020; 03/05/2020
• Supplement Dates FDA Received: 03/11/2020; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR