1.5T LINX, 15B
Report
- Report Number
- 3008766073-2020-00090
- Event Type
- Injury
- Date Received
- June 25, 2020
- Date of Event
- May 14, 2020
- Report Date
- October 31, 2023
- Manufacturer
- TORAX MEDICAL, INC.
- Product Code
- LEI
- UDI-DI
- 00855106005356
- PMA / PMN Number
- P100049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 1/20/2023.
(B)(4). DATE SENT: 09/28/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1.WHAT WAS THE DATE OF IMPLANT? (B)(6) 2018, LXMC15, LOT # 16143. 2. WHAT SYMPTOMS LEAD TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? WHEN DID THEY BEGIN? ON (B)(6) 2020, THE PATIENT NOTICED A FULL RECURRENCE OF HIS PRIOR SYMPTOMS. A CHEST XRAY DONE ON (B)(6) 2020 REVEALED THAT THE LINX DEVICE WAS OPEN IN A C CONFIGURATION, NOT AN "O" CLOSED CONFIGURATION. THE DEVICE, UPON REMOVAL FROM THE PATIENT, WAS NOTED TO HAVE AN INTACT BUCKLE BUT THE WIRE WAS FRACTURED TO THE LEFT OF THE BUCKLE. THE DEVICE WAS REMOVED INTACT. 3. WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. ON (B)(6) 2020, DR. WOULDN¿T ALLOW US TO HAVE THE X-RAY 4. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES, HAD GREAT SYMPTOMATIC CONTROL 5. WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? UNKNOWN 6. DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? I DON¿T BELIEVE SO BUT I CAN¿T CONFIRM THAT. 7. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? UNKNOWN 8. 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. UNKNOWN, DR. WOULDN¿T PROVIDE US WITH ANY IMAGING. 9. WHAT IS THE MANAGEMENT PLAN? IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? ON (B)(6) 2020 DEVICE WAS REPLACED WITH LXMC15. 10. WAS THE PROCEDURE RECORDED? IF YES CAN THE VIDEO SHARED? IT WAS NOT RECORDED.
(B)(4). DATE SENT 8/3/2020. 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 16143 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND.
(B)(4). DATE SENT: 10/31/2023. INVESTIGATION SUMMARY: A LINX DEVICE WITH A VISIBLE WELD BALL THAT DISCONNECTED FROM A WASHER WAS RETURNED TO THE ANALYSIS SITE. 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, SHOW NO ANOMALIES FOR A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. 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 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.
PC-(B)(4). DATE SENT: 5/11/2021. ADDITIONAL INFORMATION RECEIVED: OPERATIVE REPORT PROVIDED, INDICATES PATIENT HAD LINX DEVICE IMPLANTED ON (B)(6) 2018. SURGEON NOTES, IN EXPLANT REPORT ON (B)(6) 2020, THAT PATIENT HAD A DISRUPTION OF LINX DEVICE AND RECURRENT GERD. THE SURGEON NOTED, ¿THE LINX WAS HERNIATED ON THE LEFT. THE BUCKLE WAS NOTED, TO BE INTACT, BUT THE WIRE WAS FRACTURED. JUST TO THE LEFT OF THE BUCKLE¿. SURGEON ALSO STATED, ¿PATIENT WAS EXPLICIT, THAT HE WANTED THE LINX DEVICE REPLACED AND NOT A FUNDOPLICATION¿. DEVICE WAS REPLACED WITH ANOTHER 15 BEAD LINX DEVICE¿ ON (B)(6) 2021. REDACTED OP NOTES RECEIVED.
(B)(4). 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. 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 WAS THE DATE OF IMPLANT? 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. 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 A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? WAS THE PROCEDURE RECORDED? IF YES CAN THE VIDEO SHARED?
IT WAS REPORTED THAT DURING A LINX REMOVAL SURGERY, THE LINX WAS IN A C CONFIGURATION, NOT IN A CLOSED CONFIGURATION. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659047 | 1.5T LINX, 15B | ANTI-REFLUX IMPLANT | LEI | TORAX MEDICAL, INC. | LXMC15 | 16143 | 00855106005356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Required Intervention |