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

Model Number LXMC14

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Vomiting (2144); No Code Available (3191)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event was previously reported under 3008766073-2018-00161.All additional information will be captured.

Event Description

A linx device was discovered to be discontinuous via an x-ray with contrast.The linx device was implanted approximately two years ago, as one of the dr's first proctored implants.The patient presented with ongoing gerd symptoms which prompted the x-ray which discovered the discontinuous linx.

Manufacturer Narrative

(b)(4).Date sent: 08/12/2020.Additional information received: please see attached medical records.

Manufacturer Narrative

(b)(4).Date sent: 11/04/2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot 13461 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 11/8/2021.Investigation summary: it was reported that the linx device was explanted due to device separation in vivo.The device was received at torax medical for analysis on 22oct2018 under legacy complaint number (b)(4).The copy of the summary of investigation detailed in (b)(4) is listed below.The device was found to be in two parts.The device did not appear to have been cleaned prior to being sent to torax.Several links had kinks to the wires.The visual analysis found that the returned device had an exposed well ball paired with the washer side of the adjacent bead.The pulled through weld ball was found to be within the specification.The side view shows a that the weld ball is slightly flattened (i.E.Not perfectly spherical).This has been informally observed for the welding process and is not considered atypical.The washer through hole diameter was measured.The hole was found to be greater than the specification.Computed tomography (ct) analysis: the device was taken to north star imaging (rodgers, mn) for ct analysis on 07nov2018.The scans allowed for non-destructive review of the entire device including internal features such as the inner diameters of bead case and washer through-holes and wires.This assessment included assumptions including that the device was in-line with the plane of view and the contrast of pixels allowed for proper identification of the bead and the empty space around it, both of which were reasonable assumptions based on the technology used.Only the two beads adjacent to the separation were ct scanned and analyzed.Note: the ct technician inserted the exposed weld ball into bead 9 for the scan.The smallest diameters of the washer through hole at the separated junction was measured and was found to be greater than the specification.The diameter of the exposed weld ball was measured.This diameter was within the specification.The weld ball and wire did not show any significant deformation or wear.The interference between the out of specification washer through hole and the exposed weld ball was approximately 0.0006¿.Overall review of the device function and dimensions show a larger than specification washer hole diameter.The paired weld ball at the separated junction was found to be within the specification.As the device was tested to 250g tensile force in production, it is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation in vivo.The device was found to be manufactured prior to the initiation of torax capa 58 which investigated a separate device pull-through.A manufacturing record evaluation was performed for the finished device lot number 8957, and no non-conformances related to the reported complaint condition were identified.Lot 8957 was an affected lot of the 2018 linx recall.This event was originally reported under report number torax # 3008766073-2018-00161.

• Brand Name: 1.5T LINX, 14B
• 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, MN ; 6107428552
• MDR Report Key: 10396427
• MDR Text Key: 202704564
• Report Number: 3008766073-2020-00122
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2021

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: 08/31/2019
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 8957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female