MAUDE Adverse Event Report: LSI SOLUTIONS COR-KNOT; COR-KNOT MIS DEVICE

Model Number	031082
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On november 10th, 2020, lsi received an email from the team lead cardiovascular surgery stating, "we had a cor-knot® misfire and ruin a valve during a valve replacement surgery", without indication of patient harm.We attempted a follow-up with her on november 11th, but she was in a surgical case and could only speak for a minute.However, she reported no patient harm during that short call.We informed her during the call of the importance of preserving the device in question for return to lsi for assessment.We continued to try following up with her but received her out of office notice with contact information for her boss, the manager cardiovascular surgery.Accordingly, we left voicemails for the manager on november 12th and 13th and sent her requests for more information.On november 17th, we received a response from the manager who reported that the surgeon experienced difficulty releasing the 11th crimped fastener from the cor-knot® mis device.She did not report whether any of the advised techniques to release fasteners (e.G., cor-knot® mis ifu page 3, "if the crimped cor-knot® fastener does not readily release from the distal tip, ensure purple lever is released, then gently push inward and rotate the handle 90º about the shaft.If still necessary, rotate the handle back, then turn 90º in the opposite direction.If cor-knot® fastener will still not release, cut suture.").She reported, "while attempting to free the device, the suture tore, and the rivet came free with the device." the surgeon removed and replaced the prosthetic mitral valve.The manager reported they were unable to find 3 of 11 ventricular pledgets used with the first prosthetic mitral valve.We have repeatedly requested the device in question be returned for evaluation; we also mailed device return instructions to the hospital.The manager cardiovascular surgery has informed us that the device is in quarantine until their own investigation is over.We sent a reply to her on november 17th thanking her for her additional information, informing her that we would be filing a medwatch report within 30 days of the initial november 10th notification, and pointing out that we would like to include an assessment of the complaint device in our medwatch report.As of the time of this medwatch filing, they have still not released the complaint device for our evaluation.Our last information regarding the patient is that the hospital discharged the patient to a skilled nursing facility for a post-up recovery.While we have asked them to inform us of patient status changes, we have heard nothing further.Although it is not clear there has been patient harm in the above scenario, we are filing this medwatch in an abundance of caution.There has been no further response from the hospital.We are submitting this report based on the only information available to us within the mandatory 30-day reporting period.Updates to this report will be submitted if and when further information is available to us.
Event or Problem Description
Cor-knot® mis titanium fasteners were used to secure the sutures to hold the prosthetic mitral replacement valve during surgery.The 11th fastener was reported difficult to release from the cor-knot® mis device.They report, "while attempting to free the device, the suture tore, and the rivet came free with the device." the surgeon removed and replaced the prosthetic mitral valve.They reported they were unable to find 3 of the 11 ventricular pledgets used with the first prosthetic mitral valve.They further noted concern regarding "prolonged cardiopulmonary bypass pump time as the valve had to be replaced".The patient was discharged to a skilled nursing facility for a post-up recovery.

• Brand Name: COR-KNOT
• Common Device Name: COR-KNOT MIS DEVICE
• Manufacturer (Section D): LSI SOLUTIONS; 7796 victor-mendon road; victor NY 14564
• Manufacturer (Section G): LSI SOLUTIONS INC; 7796 victor-mendon road; victor 14564
• Manufacturer Contact: christopher miller ; 7796 victor-mendon road; victor, NY 14564 ; 5858696665
• MDR Report Key: 10979451
• Report Number: 1320468-2020-00005
• Device Sequence Number: 17197181
• Product Code: HCF
• UDI-Device Identifier: 00850200006278
• UDI-Public: 00850200006278
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K100593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 031082
• Device Catalogue Number: 031082
• Device Lot Number: 758088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown