MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 15 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/15/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/25/2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.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 is the lot number? what does the surgeon believe to be the source of the infection? was the infection any relations to the device? does the surgeon believe that there was any default with the device that caused the issue to be removed? if yes, please explain.Is there a plan to implant another linx device in the future? 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 during a lung transplant there was fluid in fibrotic capsule around the linx and the linx was removed due to an infection.The surgeons does not believe there is any device malfunction.

Manufacturer Narrative

Summary of event: as reported, during transluminal angioplasty of the lower limbs, the tip of a triforce peripheral crossing set's sheath separated and remains in the patient.Access was obtained in the superficial femoral artery to target a very calcified lesion in the distal superficial femoral artery.The access site was not scarred.Because the lesion was very calcified, progression of an unspecified guide was difficult, and it was directed toward the subintimal space.The user attempted to "return to the light" with a cxi catheter; however, this was unsuccessful.The cxi catheter reportedly did not malfunction but would not cross the very calcified lesion.A cook wire guide, used during the procedure, did not malfunction.The user then changed the puncture site and obtained access medial to the limb in an attempt to cross the lesion, without major progression.The complaint device was then used, which progressed a "little more" than with other attempts; however, the guide always led to the subintimal space.A power injector was used during the procedure.During the attempts to advance the complaint device, the radiopaque tip of the sheath separated.The separated tip remains in the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on four devices from a sub-assembly lot; however, all affected product was scrapped.A review of complaint history found two additional complaints for this lot number and failure mode.The product ifu cautions, "be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and that the cxi support catheter tip is extended beyond the flexor sheath tip at all times".A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as it is likely that the tip became damaged and subsequently separated during attempts to advance the sheath into the very calcified lesion.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LINX 1.5T 15 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: 19180756
• MDR Text Key: 341024792
• Report Number: 3008766073-2024-00074
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/16/2024

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: LXM15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention