MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 16 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM16

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240); Discomfort (2330)

Event Date 07/27/2023

Event Type  Injury  

Event Description

It was reported that a linx was implanted in (b)(6) 2017.Consultation again in 2022 because of increasing discomfort.X-ray without findings.In the further course growing discomfort.In (b)(6) 2023 x-ray showed a ruptured implant.Revision was performed.

Manufacturer Narrative

(b)(4).Date sent: 8/14/2023.D6a: exact implant date is unk.Assumed first day of the month and first month of the year.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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: when was the exact implant date? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com 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.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.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for finished device lot 14175.A nonconformance was identified ((b)(6) in the legacy torax nonconformance system).The nm was related to out of specification male bead cases, which is directly related to the malfunction identified in this complaint.Additional information received: recurrence reflux and dysphagia in rupture and dislocation of linx.66 year old patient.Hernia.Painful feel so pressure.40mg pantoprazole.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.

Manufacturer Narrative

(b)(4).Date sent: 10/23/2023.

Manufacturer Narrative

(b)(4).Date sent: 12/4/2023.Investigation summary photo review: x-ray images of the device in vivo were reviewed by a medical safety officer.As per medical safety officer: "two images are reviewed.The image labeled 8/3/2022 shows an intact linx device (although potion of the image is cut off).The image labeled 6/16/2023 demonstrates a discontinuous linx device." physical analysis: 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, some 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.A manufacturing record evaluation was performed for the finished device lot 14175, and an nonconformance was identified related to the malfunction reported.

• Brand Name: LINX 1.5T 16 BEAD OUS
• Type of Device: 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: 17543689
• MDR Text Key: 321140292
• Report Number: 3008766073-2023-00164
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2021
• Device Catalogue Number: LXM16
• Device Lot Number: 14175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/01/2023; 10/11/2023; 12/01/2023
• Supplement Dates FDA Received: 09/18/2023; 10/23/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR