MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent; 2/22/2024.B3: unknown; captured as awareness date lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the date of implant? what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(6).What is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that there was a patient with possible discontinuous device.Little detail at this time but plan is to removal and do partial fundoplication.
Additional Manufacturer Narrative
(b)(4) date sent: 3/27/2024 the lot number was not part of the device and has been removed.Additional information received: dob: on (b)(6) 1990 health is excellent seasonal allergies/nkda mri (2021) and (2022) ros 2023 explant surgery will be 3/15 photo analysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the barium esophagram reviewed demonstrates a discontinuous linx device located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.The device lot number is unknown; therefore, the device history record could not be reviewed.H10: lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/17/2024.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/6/2024.Investigation summary: a linx device with a visible weld ball that disconnected from a washer was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure, tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole didn¿t exhibit gross loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.The device lot number is unknown; therefore, the device history record could not be reviewed.

• Brand Name: 1.5T LINX, 14B
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18761507
• Report Number: 3008766073-2024-00038
• Device Sequence Number: 7739744
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LXMC14
• Device Lot Number: LOG165772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/12/2024; 07/16/2024; 08/01/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/27/2024; 07/17/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female