MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number LXMC13

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Hiatal or crural repair was done at implant.No mesh was used at the time of implant.Surgeon wouldn¿t have the rest of the information until he explants this device.

Event Description

It was reported that there was a discontinuous linx device at (b)(6) medical center in (b)(6).I confirmed that this was a discontinuous device.The patient likely won't have surgery until (b)(6).Device remains implanted.I will provide more information as it is available.It is unknown when implant took place.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information received: the dhr for lot: 12445 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Implant date: on (b)(6) 2017.Dob: on (b)(6) 1951.Explant scheduled for on (b)(6) 2019.The patient advised she will be undergoing explant of the linx device later this week.She indicated she doesn¿t want to make any decisions about future treatment of her gerds at this time and will not be getting another device implanted right now.She further indicated she had relief from her symptoms until september 2018.She informed the surgeon¿s office but was advised to wait until her scheduled follow up appointment in november.At that time, imaging confirmed the discontinuous device.The 15 bead device was successfully removed as a complete unit without any complications on (b)(6) 2019.What is the product code and lot number for the device? lxmc15 lot: 12485.What symptoms lead to the discovery of the discontinuous device? when did they begin? return of gerd symptoms this fall.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging along with the radiology results.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? no.Did the patient have any other surgeries in the area? no.

Manufacturer Narrative

(b)(4).Date sent: 04/23/2019.Corrected date: update to patient code: surgical intervention, implant failure.

Manufacturer Narrative

(b)(4).Date sent: 02/14/2019.Corrected date = lxmc15 (lot 12445) to lxmc13 (lot 12485).Additional information received: the chart has 12485 documented lxmc13.The dhr for lot 12485 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 12445 was an affected lot of the 2018 linx recall (recall number: z-2038-2018).

Manufacturer Narrative

(b)(4).Date sent: 03/13/2019.Device analysis: analysis found that the returned device had an exposed weld ball visible paired with the washer side of the adjacent bead.An image of the returned device is attached.The washer through hole was measured with computed tomography (ct) to be 0.02391¿ which is greater than the specification of 0.019¿ to 0.021¿ per doc.509, specification, washer.The paired weld ball diameter was found to meet specifications (diameter of 0.02441¿, specification of 0.023¿ to 0.025¿ per doc.4541, specification, wire link with weld ball linx 1.5t).Wire width measurements, pin measurements, and ct results are attached.Overall review of the device function and dimensions, excluding the out of specification washer hole, show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.The remaining device characteristics show no anomalies for a device that has been reasonably changed as part of the explant procedure.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 capa 58 which investigated a separate device pull-through.See the applicable case file for further details.This product issue was previously escalated under pia no.100609238, which resulted in the april 2018 linx recall for the through hole out of specification condition.No further corrective action is required at this time.The dhr for lot 12485 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 12485 was an affected lot of the 2018 linx recall (recall number: z-2038-2018).The dhr for lot 12485 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 12485 was an affected lot of the 2018 linx recall (recall number: z-2038-2018).

Manufacturer Narrative

(b)(4).Date sent: 12/05/2019.Per ethicon medical safety: reviewed operative notes namely the date of implant and the date of explant.No remarkable findings were noted on review of both operative records.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8220504
• MDR Text Key: 132973888
• Report Number: 3008766073-2019-00236
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Catalogue Number: LXMC13
• Device Lot Number: 12445
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 11/19/2019
• Patient Sequence Number: 1