MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. CHORD-X 2.0 SUT 18MM 1/2CIR 20MM LOOP; NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE FOR CHORDAE TENDI

Model Number	CXL-20-1812-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2023
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 initial notification, "after repair of mitral valve with chord-x, the surgeon done water test and noticed a spontaneous broken of chord-x and a loss of pledget.He tried to recover the pledget with the help of endoscope in ventricle without success, the pledget is now missing.".
Additional Manufacturer Narrative
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.Section d4 updated: udi number and expiration date added.
Additional Manufacturer Narrative
The manufacturing records for lot number z206031400 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.Artivion received the product back and attempted a sample evaluation.2 of the 5 remaining chord-x loops were returned to artivion for examination.Upon receipt, the samples were visually examined and no deficiencies were noted.Due to the lack of information/evidence, the exact mode of failure is not clear.If the sample that failed was returned or photographed, the failure mode may have been determined and further testing could be performed to replicate it.Without knowledge of the exact nature of the failure, exploratory testing of the remaining samples could lead to misleading results.In addition, it is unlikely that the suture failure occurred due to insufficient tensile strength.Suture strength testing is performed by artivion for each sterilization lot of chord-x loops.Lots must receive passing results before being approved for release to customers.With the currently available information/evidence, the exact mode of failure is not easily determinable, which disallows the possibility of exploratory testing.Because of this, the root cause is unknown and unable to be determined.This reported event does not have patient impact; therefore, a risk report is not required.However, the chord-x file was reviewed.The risk file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu (instructions for use).A root cause could not be determined.The manufacturing records 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.There is no indication that an error or deficiency occurred at artivion, previously cryolife/jotec.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.No actions are required at this time.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.

• Brand Name: CHORD-X 2.0 SUT 18MM 1/2CIR 20MM LOOP
• Common Device Name: NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE FOR CHORDAE TENDI
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln,, bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17930346
• Report Number: 1649833-2023-00040
• Device Sequence Number: 17751179
• Product Code: PAW
• UDI-Device Identifier: 00813570020237
• UDI-Public: 00813570020237
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2023

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: 11/04/2023
• Device Model Number: CXL-20-1812-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 10/11/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/04/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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