MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX NEXT GEN SIZER; ANTI-REFLUX IMPLANT

Model Number LST

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

It was reported that during a linx implant when they opened the device it had a foreign metal object attached to it.It was removed and the device was implanted successfully.

Manufacturer Narrative

(b)(4).Investigation summary : according to the information received, the surgeon reported that during 15-bead linx implant procedure he observed a piece of metal that was magnetized and stuck on a linx device.The foreign material (fm) was not observed on the linx prior to placing it in the abdominal cavity.The fm was removed, and the surgeon inspected the linx device laparoscopically for damage.Since the linx device was observed to be intact (no signs on break and the magnets stretched as expected), the surgeon placed it around the esophagus and clasped it.The fm was returned for evaluation and was identified to be half of a ring of magnet of a linx sizing tool (lst) device.The magnet had some burrs from breakage and the coating was peeling.Optical microscopy images indicated that the fracture surface was brittle and no material defects such as pores or uneven grain sizes were observed.It is presumed that the cause of the fracture is overloading of the ring magnet.It is unknown what caused the overloading.The dhr for lot v9494r was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: where was the metal part found (inside the tray, inside the sterile pouch, outside sterile pouch, when placing the linx device in the patient)? noticed in the case once device was pulled through the port.Was the metal part in contact with the linx device? it was stuck to one of the beads, that¿s how he noticed it.When was the metal part found (before opening the pouch, before placing the device in the patient, etc.? after device was in the patient.Most likely the tip of the sizer.Was the metal part, at any point, in the patient? yes.What linx sizing tool was used during the procedure (lssus or lst)? lst.What was the lot number on the linx sizing tool? lst-sizer lot # v9494r.Could you please send us the linx sizing tool that was used during the procedure? tossed after the case.I have the metal piece just waiting to send it in.Were any patient consequences, if yes, please describe: dr.Sent patient for an upper gi on 7/27 and linx was where it was supposed to be and no pt or device problems, patient is doing very well.Robotic 8mm port/ trocar.Additional information provided: i did not get the message correct the first time, a little confusing.What actual occurred is the surgeon (does procedure robotically.Surgeon noticed the fragment once the linx was in the patient but wasn¿t classp.Surgeon pulled device back out and kept the magnetic piece on the linx so he analyze the individual beads.He called me from the operating room before clasping.Once i started digging in a little more, both myself and the surgeon now can tell this is most likely from the end of the sizer.Commented that he pushed sizer with force to get it through port.Surgeon noticed the fragment once the linx was in the patient but wasn¿t clasp.Surgeon pulled device back out and kept the magnetic piece on the linx so he analyze the individual beads.Lxmc15- lot # 25208 and expired 2023-07-02.Linx surgery was on 7/26.Additional information was requested, and the following was obtained: is there any current x-ray report post op that you can share with us.It is imperative that any questions that we have sent out be answered if possible.Answer= i asked the surgeon and he said he was trying to find a way that he could send it but said because of hospital policy it was a nightmare.That statement was from the surgeon.Additional information was requested, and the following was obtained: was the foreign matter part of the linx sizer? believe so but would like to know from your analysis.Was the foreign matter part of the linx device? no.Was there any part of the linx sizer left in the patient? not that i or surgeon is aware of.If there was part of the linx sizer that was left in the patient, what is the patient management for removing the part of the sizer? no, surgeon using robotic visualization did not see any additional fragments.Was everything (besides the linx device) removed from the patient? surgeon said that he is confident that nothing left in patient and patient is doing well.What is the current status of the patient this week? doing well and no concerns.Could we please received a copy of the upper gi on 7/27? i¿ve been trying to get from the surgeon, i emailed him on friday 8-27 and saw him 8-30, both occasions he said he would respond when he had time.Additional information received: we obtained a plain film of the patient's abdomen after surgery.It shows the linx device in good position and no other retained metallic foreign body.The patient is doing very well.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: the additional information states ¿we obtained a plain film of the patient's abdomen after surgery.¿ is it possible to obtain the film and send it to (b)(4)? if we can help in any way to have the x-ray images released to us please let us know.Additional information from medical safety officer: i reviewed an operative report associated with this compliant.The note described a robotic hiatal hernia repair and placement of a linx device.A ¿pop-off¿ technique was used to size the esophagus.Popoff occurred at 11/12 and a 15- bead device was placed correctly between the esophagus and posterior vagus nerve.Following placement, the surgeon noted a miscellaneous piece of metal attached to the device.The surgeon and the assistants were unable to determine the origin of the piece of metal.It was concluded not to have come from the linx device, as the appearance of the device showed no evidence of any defect.The metal piece was retrieved and removed from the patient.

Manufacturer Narrative

(b)(4).Date sent: 11/15/2021.Additional information received: dr.Indicated that the device felt stuck so he ¿yanked¿ the sizer out of the metal trocar which broke the ring magnet.He retrieved the piece and there was no patient consequence.He now does not use metal trocars due to the attraction with the magnet(s) in the sizing tool.This was a robotics case.Additional investigation summary note: as per the additional information received the probable cause of the failure is user related.

• Brand Name: LINX NEXT GEN SIZER
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 12622928
• MDR Text Key: 282012794
• Report Number: 3008766073-2021-00205
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 10855106005438
• UDI-Public: 10855106005438
• Combination Product (y/n): N
• PMA/PMN Number: K201035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: LST
• Device Catalogue Number: LST
• Device Lot Number: V9494R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1