MAUDE Adverse Event Report: LSI SOLUTIONS, INC COR-KNOT; COR-KNOT MINI COMBO KIT

Model Number 031350

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

Patient Problem Death (1802)

Event Date 04/07/2020

Event Type  Death  

Manufacturer Narrative

We have no information about any post-mortem analysis or autopsy reports at this time.It is not possible to determine the reason or reasons for this sad outcome.There is no information known to us to suggest that the cor knot® fastener failed.Furthermore, the surgeon stated that he would continue to use cor-knot® devices and fasteners.While the morbidity and mortality risks associated with heart surgery have substantially declined over the past six decades, unfortunately such risks are unlikely to ever be completely eliminated.Significant bleeding from an aortic cannulation site is a well-recognized complication that often yields serious, even fatal, outcomes.The root cause of this patient's tragic demise will likely never be fully known.While we have very little information at this time the proper use of a cor-knot® titanium fastener to mechanically hold a 2-0 polyester suture at this closure site is highly likely to provide more than ample security for permanently holding this suture together.A failure of a titanium fastener under these conditions or any other related clinical conditions has never been reported despite having nearly 8 million titanium fasteners in over 463,000 cardiac surgery patients over the past decade in now 64 countries.The same titanium fasteners from the same devices were used to secure the prosthesis used in the mitral valve surgery, apparently without compromise.Based on the exceptionally reliable history of the use of titanium fastener to fasten sutures in surgery and the recognized potential limitations of suturing aortic cannulation sites, we believe that the tragic bleeding experienced by this patient was very unlikely to be caused by the failure of the titanium fastener to perform as intended.

Event Description

A patient required a mitral valve operation, which utilized aortic cannulation for cardiopulmonary bypass.We do not know if this operation was performed with direct open access or through a less invasive means.The aortic cannulation site was reportedly closed with a 2-0 ethibond® suture, that was secured with a cor-knot® titanium fastener.Eighteen hours after this initial surgical procedure, the patient was taken back to the operating room with concerns regarding potential bleeding.A second surgeon discovered that the patient was reportedly bleeding from the aortic cannulation site.The patient subsequently expired.

• Brand Name: COR-KNOT
• Type of Device: COR-KNOT MINI COMBO KIT
• Manufacturer (Section D): LSI SOLUTIONS, INC; 7796 victor-mendon road; victor, ny
• Manufacturer (Section G): LSI SOLUTIONS, INC; 7796 victor-mendon road; victor, ny
• Manufacturer Contact: christopher miller ; 7796 victor-mendon road; victor, ny ; 8696665
• MDR Report Key: 10061107
• MDR Text Key: 191112144
• Report Number: 1320468-2020-00406
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 031350
• Device Catalogue Number: 031350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death