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

Catalog Number LXMC16

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); Hernia (2240)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/25/2024 b3: only event year known: 2017.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.No lot number was provided therefore a device history could not be done.Additional information received: broken linx- wire pulled through bead- recall lot did patient undergo an mri since device implant? if yes, when and what mri strength? no 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 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? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? 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 Description

It was reported that there was a barium- 4/18/18- abnormal barium swallow.Passage of material was hindered at the level of the linx device at the gastroesophageal junction.Barium- 8/24/21-.Normal esophageal motility was observed with adequate clearing of the thin liquid barium bolus and mechanical soft food bolus with two or fewer stripping motions.Incomplete clearing of the solid food bolus requiring more than two stripping motions.Small hiatal hernia suggested.Barium- 09/21/23 linx failure with small recurrent hiatal hernia.Delayed esophagogastric clearance on prone swallow.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 3/12/2024.Investigation summary: a linx device was returned to the analysis site with a visible weld ball that disconnected from a washer and a washer separated from a female bead case.The washer that separated from the female bead case was observed to be bent outwards with two weld tracks.Two weld tracks were also observed on the female bead case where the washer separated.These findings suggest that the washer was pulled out of the female bead case due to external forces applied during an explant procedure.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 and the washer separated, show no anomalies for a device that has been reasonably changed as part of the explant procedure, tooling marks were noted.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 non-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.

Manufacturer Narrative

(b)(4).Date sent: 2/16/2024.Additional information received; dob (b)(6) 1960.Bmi 31.1.Reviewed medications cyclobenzaprine 10 mg tablet take 1 tablet by mouth three times a day as needed (b)(6) 20 filled desvenlafaxine succinate er 100 mg tablet,extended release 24 hr take 1 tablet by mouth every day 08/12/21 filled hydrocodone 7.5 mg-acetaminophen 325 mg/15 ml oral solution 11/19/17 filled nystatin 100,000 unit/gram topical cream (b)(6) 17 filled rizatriptan 10 mg tablet take 1 tablet by mouth once, may repeat at 2 hours if needed, not to exceed 30mg in 24 hours 04/18/21 filled zolpidem 10 mg tablet take 1 tablet by mouth every day at bedtime as needed (b)(6) 21 filled np thyroid 75mg 150mg testosterone pellet reviewed problems hypothyroidism - onset: (b)(6) 2018.Surgical history not reviewed (last reviewed (b)(6) 2018) hernia repair.61-year-old is status post laparoscopic paraesophageal hernia repair with magnetic sphincter augmentation performed at bsw in (b)(6) 2017 followed by repair of recurrent paraesophageal hernia (with linx left in place) in feb 2020.She reports occasional mild reflux but is she is doing well overall.8/10-barium swallow showed normal esophageal motility but incomplete clearing of the solid food bolus requiring more than two stripping motions.A small hiatal hernia was suggested.Gerd-hrql-8 lpr-rsi-6 ehas-1+13=14.General: no acute distress, alert, well nourished heent: no scleral icterus, no lymphadenopathy cv: regular rate and rhythm pulm: ctab, nonlabored breathing abd: soft, nondistended, nontender.Well healed incisions extremities: no calf tenderness, erythema.61-year-old is status post laparoscopic paraesophageal hernia repair with magnetic sphincter tcpa-seton family of doctors.(b)(6).(id #1097585, dob: (b)(6) 1960)augmentation performed at bsw in (b)(6) 2017 followed by repair of recurrent paraesophageal hernia (with linx left in place) in (b)(6) 2020.Occasional mild reflux but is doing well overall.8/10-barium swallow showed normal esophageal motility but incomplete clearing of the solid food bolus requiring more than two stripping motions.A small hiatal hernia was suggested.Gerd-hrql-8 lpr-rsi-6 ehas-1+13=14-encouraged pepcid complete-follow-up in 1 year 1.Gastroesophageal reflux disease without esophagitis k21.9: gastro-esophageal reflux disease without esophagitis.

• Brand Name: LINX 1.5 16 BEAD US
• 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: 18582029
• MDR Text Key: 333747579
• Report Number: 3008766073-2024-00019
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 02/06/2024; 03/11/2024
• Supplement Dates FDA Received: 02/09/2024; 02/16/2024; 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 95 KG