MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP; NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE

Model Number	CXL-20-1838-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion is accurate or has been confirmed by artivion.
Event or Problem Description
According to the initial report, after implant of this chord-x device, it was discovered that the papillary stitch/arm had been cut/severed and released from the papillary muscle.Surgeon stated they could not find the pledget that slipped off the broken papillary anchor and believed it must have been lost in the patient's left ventricle.
Additional Manufacturer Narrative
The manufacturing records for cxl-20-1838-20 lot z226008100 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.According to the chord-x ifu (instructions for use) it is specifically recommended : ¿as with any suture, care should be taken to avoid damage when handling.Avoid crushing or crimping the suture with surgical instruments or exposing the suture to sharp edges, which may adversely affect the tensile strength of the suture.Avoid using knot pushers with imperfections such as burrs or flashing which may damage the suture.¿ as the surgeon described in this case of chord detachment, she used metal knot pushers to tie down the papillary stitch and during the in-service it was relayed and she agreed that finger tying would be a better procedure vs.Using metal knot pushers.The root cause of the chord-x system detaching from the papillary muscle is most likely the use of the metal knot pushers that may have had burrs or flashing that adversely affected the tensile strength of the chord-x suture.The corrective action was to perform the in-service and wet lab for the surgeon and staff, this was successfully accomplished as evidenced by the surgeon and team successfully performing an anterior mitral repair during the wet lab.They were also given resources and contact information for further questions.Risk has been reduced as low as possible and overall 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 artivion is accurate or has been confirmed by artivion.References: on-x chord-x pre-measured loops and suture system ifu http://www.Onxlti.Com/ifu.
Event or Problem Description
According to the initial report, after implant of this chord-x device, it was discovered that the papillary stitch/arm had been cut/severed and released from the papillary muscle.Surgeon stated they could not find the pledget that slipped off the broken papillary anchor and believed it must have been lost in the patient's left ventricle.

• Brand Name: CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP
• Common Device Name: NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 21068858
• Report Number: 1649833-2025-00076
• Device Sequence Number: 3493441
• Product Code: PAW
• UDI-Device Identifier: 00813570020282
• UDI-Public: 00813570020282
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 Expiration Date: 03/06/2025
• Device Model Number: CXL-20-1838-20
• Device Lot Number: Z226008100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2022
• 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: Life Threatening
• Patient Sex: Unknown