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

Model Number SGPV00

Device Problem Material Integrity Problem (2978)

Patient Problems Congenital Defect/Deformity (1782); Death (1802)

Event Date 12/09/2019

Event Type  Death  

Manufacturer Narrative

According to the report from the surgeon: "the homograft appeared fine during the initial implant (norwood arch reconstruction) but we noticed a few bleeding sites that required suturing, and each additional suture led to tearing of the homograft.Additional manipulation of the tissue resulted in further tearing at multiple sites away from the suture line.We were re-warming from circulatory arrest at the time, so we elected to cool back down and completely replace the entire homograft.The second graft was perfectly fine.The patient¿s reconstruction was ultimately fine, but the prolonged operation led to ecmo [extracorporeal membrane oxygenation], but the patient should do well.There were no observable deformities of the tissue.The homograft came out in pieces, fragmenting while being removed." additional information was received stating: ¿the child died due to fungal sepsis.The patient had trisomy 21 and was felt to be a high risk candidate for palliation.¿ the processing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications for release.Information obtained from the operative procedure note indicated ¿the previously thawed and trimmed pulmonary homograft was used to augment the arch in the usual fashion using running 7-0 prolene sutures¿ and that ¿the aortic arch reconstruction appeared quite nice.¿ after returning to cardiopulmonary bypass (cbp), a ¿fair amount of bleeding was noted from the aortic reconstruction.¿ the surgeon attempted to repair this but noted that the patch was extremely friable and in fact tore while the surgeon attempted to place repair stitches.At this point, the surgeon felt there was something wrong with the patch and elected to replace it.The old homograft patch material was removed, along with all the ductus stent material (placed during the previous hybrid procedure) from the descending thoracic aorta, ¿thinking that might have contributed to some friability and tearing of the homograft patch.¿ the surgeon then took a ¿¿freshly thawed and trimmed pulmonary homograft patch and re-augmented the arch again in the same fashion using running 6-0 prolene sutures.¿ following the second arch reconstruction, the surgeon noted the ¿homograft reconstruction appeared quite optimal with no evidence of bleeding or any friability of the homograft patch.¿ there were additional complications associated with the subsequent glenn procedure, including significant coagulopathy, unrelated to the original explanted pulmonary homograft used to reconstruct the aortic arch, that required additional cbp time, blood products, topical hemostatic agents, and post-operative extra-corporeal membrane oxygenation (ecmo).The data regarding risk factors for requiring extracorporeal membrane oxygenation (ecmo) after a norwood operation are limited.A retrospective study of 64 norwood procedures by friedland-little assessed risks factors associated with emco following the norwood (friedland little).In univariate analysis, longer cardiopulmonary bypass (cpb) time was associated with the need for postoperative ecmo, and multivariate logistic regression identified longer cpb time to be independently associated with the need for postoperative ecmo (friedland-little 2014).In addition, risk factors for ecmo post-norwood appear to be similar to the risk factors for early mortality post-norwood (friedland-little 2014).The cause of the homograft friability, resulting in graft failure and explant, cannot be determined from the information available.However, possible explanations include microfractures due to cryopreservation, too much tension along the suture lines due to incorrect sizing by the surgeon during trimming of the sgpv00 into a patch that was used to reconstruct the aortic arch, as bleeding was noted following re-pressurization of aorta.In this situation, prolonged cpb time and subsequent ecmo was related to the overall complexity of the procedure, including the need to replace the homograft during aortic arch reconstruction and complications associated with the glenn procedure.

Manufacturer Narrative

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

Event Description

According to the report from the surgeon: "the homograft appeared fine during the initial implant (norwood arch reconstruction) but we noticed a few bleeding sites that required suturing, and each additional suture led to tearing of the homograft.Additional manipulation of the tissue resulted in further tearing at multiple sites away from the suture line.We were re-warming from circulatory arrest at the time, so we elected to cool back down and completely replace the entire homograft.The second graft was perfectly fine.The patient¿s reconstruction was ultimately fine, but the prolonged operation led to ecmo [extracorporeal membrane oxygenation], but the patient should do well.There were no observable deformities of the tissue.The homograft came out in pieces, fragmenting while being removed.".

• 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
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 9503811
• MDR Text Key: 177885374
• Report Number: 1063481-2019-00077
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/02/2023
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Device Lot Number: 147026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6