MAUDE Adverse Event Report: LSI SOLUTIONS, INC. COR-KNOT; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number 030800

Device Problem Failure to Fire (2610)

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

The surgeon stated that she did not know the cause of the suture breakage during the first prosthesis installation.She has used the cor-knot® devices and titanium fasteners for 5 years in her practice and also during her training.She stated this was the first time that anything has ever happened like this while she was using the cor-knot® device.She wanted to provide the manufacturer with feedback and return the cor-knot® devices so they could be inspected to determine whether the cor-knot® devices were defective.The four returned devices were received on 16 aug 2018 and their evaluation was promptly completed.Each of the four devices worked as intended, showing no defects and producing fully crimped, strong titanium fasteners on suture and easily trimming away suture tails.After removal of the returned titanium fastener from the returned device with the uncrimped titanium fastener still in its tip, the device readily re-loaded and demonstrated excellent device functionality upon rigorous tested.The returned titanium fastener was a completely uncrimped, unblemished normal titanium fastener without any defect or compromise.Based on the history known to us at this time, plus the evaluation and analysis of the returned devices, this very unfortunate outcome most probably resulted from an unintended, premature suture breakage before the titanium fastener could be placed.Suture breakage is known to occur from suture defects or damage or from too much applied tensioning.All of the returned cor-knot® devices tested as expected and were without defect.The returned titanium fastener showed no indication of any crimping action and the device it was removed from tested well prior to shipping, performed well in the operating room prior to the suture breakage and demonstrated excellent crimping results without any defects on subsequent evaluation.A search for complaints against the same manufacturing lot numbers showed zero complaints for any reason.Atrio-ventricular groove dissociation is a rare, dreaded known complication to this type of surgery and is associated with a very high increased morbidity and mortality risk.Suture breakage is not uncommon in complex surgical operations, but usually not reported or very significant.The cor-knot® devices and titanium fasteners used in this patient appear to perform very well providing results as intended without any evidence of design flaw or manufacturing defect.This very challenging post-operative course for this patient appears to be related to suture breakage and not to a problem with the titanium fastener product utilized in this surgical procedure.(b)(4).

Event Description

A (b)(6) patient required the placement of three prosthetic valves in the mitral location during a surgical mitral valve replacement procedure.Seventeen (17) sutures were placed around the mitral annulus for the first prosthesis installation attempt.After successfully securing the first 11 sutures with cor-knot® titanium fasteners using two cor-knot® mis devices from the same kit, the 12th suture broke prior to crimping the fastener.It is unclear whether the actuating lever of the device was squeezed during the suture breakage.The device with the uncrimped fastener still in the device tip was removed from the patient.The surgeon removed this first prosthetic valve along with the sutures and the installed titanium fasteners.While securing the second mitral prosthesis, the surgeon noticed unexpected bleeding and determined an atrio-ventricular groove dissociation had occurred.This complication required the removal of the second prosthesis to enable the repair of the dissociation.After completion of the dissociation repair, a third prosthesis was successfully installed.Note: the surgeon elected to open a second kit of two cor-knot® mis devices to use to secure the second prosthesis and then the third prosthesis without any problems reported with the devices or fasteners.All four devices used in this case, including the one with the uncrimped fastener, were returned to the manufacturer at last report, the patient's chest was reported as "open and packed" with the patient requiring extra-corporeal membrane oxygenation.The patient reportedly developed sepsis.

• Brand Name: COR-KNOT
• Type of Device: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon road; victor NY 14564
• Manufacturer (Section G): LSI SOLUTIONS, INC.; 7796 victor-mendon road; victor NY 14564
• Manufacturer Contact: christopher miller ; 7796 victor-mendon road; victor, NY 14564 ; 5858696665
• MDR Report Key: 7836855
• MDR Text Key: 118888194
• Report Number: 1320468-2018-00003
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 030800
• Device Lot Number: 725484, 726879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening
• Patient Age: 62 YR