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

Model Number 030850

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

In the nearly 18 years of clinical use of this type of product in over 500,000 patients, this is the first time lsi solutions® (lsi) has received a report of a titanium fastener product found not in its intended location in a patient.With over (b)(4) phone calls to reporting facilities so far, lsi has not yet been able to obtain any more information beyond that reported in medwatch (b)(4).We will continue to reach out to the reporting facility.Once more information is received, the open investigation (lsi complaint number (b)(4)) will be aggressively pursued to enable a better understanding and develop a course of action regarding this event.Fortunately, this aortic valve replacement patient was reportedly "discharged on pod#3 having tolerated the procedure very well." we interpret this medwatch report to say that about 2.5 years after surgery, this patient apparently suffered a fall while running.Subsequent light-headedness lead to a ct finding of a reported intracerebral "5 mm metallic density." many questions remain.For example, was the object noted on ct consistent with a titanium fastener and was it crimped or non-crimped? with over 5.3 million fasteners in patients to date without a single previous report of dislodgment, including the 15 titanium fasteners reportedly holding in the cardiac prosthesis in this patient, there are no data known to us demonstrating a technology failure.Once further information is available regarding this reported incidence, lsi will provide a supplement to this narrative to better address whether there may have been a "device malfunction - that is, the device did not do what it was supposed to do" or whether there was some other possible cause for this unfortunate finding, such as an error in loading or use technique.

Event Description

As per user facility report # (b)(4) received by lsi on 30nov2017: the patient underwent an aortic valve replacement.The patient was able to be discharged on pod#3 having tolerated the procedure very well.In about 2.5 years later, the patient was seen in the ed after suffering a fall while running; the patient denied hitting his head or neck.Patient was discharged home from ed.A few days later, the patient underwent a head ct with lightheaded being documented as the reason for the imaging study.The ct revealed a "5mm metallic density foreign body in a left parietal sulcus is favored to be intravascular within a left middle cerebral artery branch.There appears to be occlusion of the branch distal to the foreign body." the patient's operative note indicates sixteen sutures were used ("secured using the cor-knot system").A gated ct was performed about 5 months later which revealed "bioprosthetic aortic valve is identified.Fifteen fasteners are noted at the periphery of the bioprosthetic aortic valve.".

Manufacturer Narrative

The patient involved in this report independently contacted our office first on (b)(6) 2017, through a phone call to our customer service line.He has also subsequently sent our company several emails regarding his perspective on this issue.The patient requested additional phone conversations, which occurred on (b)(6) 2018.Fortunately, the patient continues to have no medical problems related to this occurrence.He is highly intelligent, well informed and insightful.He has conducted significant related research, which he is interested in sharing.While we stated that we did not want to receive any personal medical information, the patient elected to send us some of his related medical information, including radiographic studies.He said he felt we should see it.Throughout our contact with this patient, he has frequently told us that he does not believe our technology malfunctioned.He stated he thought it was a loading issue.We agree the head x-ray print provided by the patient shows an object that appears to be a completely non-crimped titanium fastener.According to the patient and consistent with the information he provided to us, we believe this occurrence is most likely related to a technique issue and not a technology malfunction.Lsi has not been able to obtain any further information from the reporting facility and the devices are not available for evaluation.

• 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 Contact: samantha duffy ; 7796 victor-mendon road; victor, NY 14564 ; 5858696699
• MDR Report Key: 7156890
• MDR Text Key: 97377989
• Report Number: 1320468-2017-00001
• Device Sequence Number: 1
• Product Code: GAW
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: 030850
• Device Lot Number: 17291
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR