MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH SG PULMONARY HEMI-ARTERY; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT

Model Number SGPH00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 06/02/2020

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 received on 7/31/2020, patient had hypoplastic left heart.On (b)(6) 2020 sgph00 serial number (b)(4) was implanted as part of norwood procedure.On (b)(6) 2020 patient received a heart cath stent lpa.On (b)(6) 2020 the patient underwent a heart transplant.

Manufacturer Narrative

The available information was reviewed.The certificate of assurance for cryopatch sg pulmonary hemi-artery 11487387 was reviewed.All attributes identified during inspection were documented appropriately on the certificate of assurance.There are no rejectable attributes.Given the limited information available we know the patient is a 4-month-old presenting with hypoplastic left heart (hypoplastic left heart syndrome, hlhs) and received the 60mm x 4.0cm cryopatch sg pulmonary hemi-artery (sid (b)(6)) on (b)(6) 2020.The implant summary card for this patch indicates the patch was used for a norwood procedure, although no operative notes are available at this time, so it is unknow as to how or where the patch was used during this surgical procedure.Approximately 6 weeks post-operative, it was reported that the patient underwent a heart catherization on (b)(6) 2020.It appears that a stent was placed into the lpa, which presumably is the left pulmonary artery.Stent placement would have been to treat a stenosis in this anatomic location and is considered standard of care.As we do not know where the patch was placed during the incident operation, it remains unclear if the stent placement involved the patch material directly or native artery or a combination of both.Seven weeks later it was reported that this patient underwent a heart transplant procedure, which is a well-established treatment option for patients with hlhs.The root cause of the reported events and the relation to the branch patch cannot be determined from the available information.Fibrosis and technical complications related to surgical technique cannot be excluded.¿graft stricture" is listed in the cryopatch sg ifu as a potential known adverse event associated with the use of patch material in cardiac reconstruction (cryopatch sg ifu).No increase in occurrence has occurred.No new risks were identified.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: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10459375
• MDR Text Key: 204538107
• Report Number: 1063481-2020-00014
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SGPH00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other