MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH SG PULMONARY HEMI-ARTERY; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number SGPH00

Device Problems Degraded (1153); Fracture (1260)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

The sg pulmonary hemi-artery (sgph00 serial number (b)(4)) was implanted during a norwood procedure aortic repair.According to the surgeon, the tissue was noted as particularly thin, felt mushy and had a crack.The integrity of the graft was suspect as it would not hold suture.As the patient came off pump, the graft fell apart.The surgeon attempted to repair and dealt with bleeding for 2 hours.The patient was transported to icu, more bleeding was noted.Chest entered in the icu for additional repair and to control bleeding.This continued for 2.5 hours.As of the next morning, the patient was stable.

Manufacturer Narrative

There are no graft specific non-conformances (ncs) associated with cryopatch synergraft pulmonary hemi-artery (sgph00), serial identification number (sid) (b)(6).There are no ncs associated with the transfer or handling of this allograft.The sgph00 was implanted in a 7 day old male patient on (b)(6) 2019.The sgph00 was used to reconstruct the patient¿s hypoplastic aortic arch as part of the norwood procedure.The norwood procedure is the first stage of a 3-part surgical palliation procedure to correct hypoplastic left heart syndrome (hlhs).Hypoplastic left heart syndrome (hlhs) constitutes a spectrum of cardiac anomalies that result in underdevelopment of left-sided heart structures.It is characterized by underdevelopment of the aorta, aortic valve, left ventricle, mitral valve, and left atrium, resulting in severe or total obstruction of blood flow from the left ventricle.(sivanandam 2011).Coarctation of the aorta (narrowing of the aorta) is the most frequently associated anomaly with hlha, and it may impede retrograde blood flow to a diminutive ascending aorta (atik 2006).Without some form of intervention, hlhs is universally fatal within the first weeks of life and is the most common cause of cardiac-related death in children less than one month of age.The four basic underlying goals of the norwood procedure include: - relieve systemic outflow obstruction, - provide unobstructed coronary blood flow, - create a nonrestrictive atrial septal communication, and - provide an adequate and regulated source of pulmonary blood flow (ashcraft 2008).The goals of norwood procedure are to relieve systemic outflow tract obstruction, provide nonrestrictive coronary blood flow and adequate pulmonary blood flow, and create a nonrestrictive atrial septal defect (feinstein 2012).The norwood palliation of hlhs includes constructing a neo-aorta utilizing the pulmonary root, ascending aorta, and cryopreserved homograft tissue (the patch material).The ductal tissue is resected and the augmentation of the aortic arch and site of coarctation is carried out.Pulmonary blood flow is provided by placement of a shunt.The norwood procedure is performed shortly after birth within the first week of life.The second procedure, known as the bi-directional glenn or hemi-fontan, is performed between 3-6 months of age, and the final stage, known as the fontan, between 18 months ¿ 5 years of age.Cardiac allograft tissue is very brittle in the cryopreserved state and may be subject to cracking during handling and thawing process.Cryopreserved allografts are fragile and must be handled with care while in the froze state to avoid causing damage to the allograft or packaging.The precautions section of the cryopatch sg ifu states, ¿do not implant the cryopatch sg if the patch is damaged.¿ the surgeon stated that he observed a ¿crack¿ in the tissue yet still implanted the cryopatch sg.The root cause for the reported event is most likely cryopreservation damage to the cryopatch sg.It is unknown whether the damage occurred during storage, transport, or during the thaw and rinse process.The precautions section of the cryopatch sg ifu states, ¿do not implant the cryopatch sg if the patch is damaged¿; however, the cryopatch was implanted despite a noted crack.Adequate precautions and warnings regarding tissue damage are provided in the ifu.All risks identified have been mitigated as far as possible and residual risk is acceptable.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: CRYOPATCH SG PULMONARY HEMI-ARTERY
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8975296
• MDR Text Key: 157468102
• Report Number: 1063481-2019-00050
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K101866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Model Number: SGPH00
• Device Catalogue Number: SGPH00
• Device Lot Number: 150890
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/28/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 7 DA