MOTIVA FLORA TISSUE EXPANDER
Report
- Report Number
- 3012883202-2024-03976
- Event Type
- Injury
- Date Received
- February 21, 2024
- Date of Event
- January 9, 2024
- Report Date
- July 8, 2024
- Manufacturer
- MOTIVA USA LLC
- Product Code
- LCJ
- PMA / PMN Number
- K211676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AFTER ANALYZING THE REPORT AND THE EVIDENCE, WE CONFIRMED A ROTATION ACCORDING TO THE CLINICAL EVIDENCE PROVIDED. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. CLINICALLY, APPARENT ROTATION MORE COMMONLY OCCURS WHEN AN IMPLANT FLIPS BACK TO FRONT THE BACK SURFACE OF THE IMPLANT BECOMES ANTERIOR. PATIENTS WITH THIS PROBLEM USUALLY REPORT SUDDENLY NOTICING A DIFFERENCE IN THE APPEARANCE OF THEIR BREAST(S). (AHMAD & LISTA, 2017). EACH PATIENT SHOULD BE GIVEN THE ESTABLISHMENT LABS "MOTIVA FLORA® TISSUE EXPANDER: INFORMATION FOR THE PATIENT" DOCUMENT DURING HER SURGICAL CONSULTATION. IT IS THE SURGEON'S RESPONSIBILITY TO ENSURE THAT THIS HAPPENS, AND IT IS A REQUIREMENT FOR THE USE OF THE DEVICE. THE PATIENT MUST BE GIVEN ENOUGH TIME TO READ AND COMPLETELY UNDERSTAND THE INFORMATION REGARDING THE RISKS, BENEFI TS, AND RECOMMENDATIONS ASSOCIATED WITH TISSUE EXPANDER-BASED BREAST RECONSTRUCTION SURGERY. IN ORDER TO DOCUMENT A SUCCESSFUL INFORMED CONSENT PROCESS, THE PATIENT, A WITNESS, AND THE SURGEON SHOULD SIGN THE "INFORMED CONSENT DOCUMENT," WHICH WILL BE PART OF THE PATIENT'S MEDICAL FILE. THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: USE OF TRUEFIXATION® SYSTEM (TFS). MOTIVA FLORA® TISSUE EXPANDER - TRUEFIXATION® SYSTEM INCLUDES TWO FIXATION TABS, MADE OF REINFORCED SILICONE, WHICH ARE SUTURED TO THE ADJACENT BREAST TISSUE TO PREVENT POSSIBLE ROTATION AND/OR DISPLACEMENT AFTER SURGERY, WITH THE SUBSEQUENT DISTORTION IN THE EXPECTED RESULTS. MOTIVA FLORA® TISSUE EXPANDER TRUEFIXATION® SYSTEM HAS AN OPENING IN EACH TAB TO ALLOW THE SURGEON TO AFFIX THE DEVICE'S TAB TO THE ADJACENT BREAST TISSUE WITH A SINGLE STITCH. CAUTION MUST BE TAKEN IN ORDER NOT TO DAMAGE THE EXPANDER SURFACE DURING THIS MANEUVER; THIS IS ACCOMPLISHED BY RETRACTING THE EXPANDER WHILE THE STITCH IS PLACED IN THE ADJACENT BREAST TISSUE. TO PASS THE SUTURE THROUGH THE OPENING, IT IS NOT NECESSARY TO KEEP THE NEEDLE IN THE SURGICAL AREA. IT IS DONE ONLY BY INSERTING THE SUTURE THROUGH THE HOLE, WITHOUT THE NEEDLE, AND TYING IT, AVOIDING DAMAGE TO THE SURFACE OF THE TISSUE EXPANDER. BRAIDED PERMANENT SUTURE IS RECOMMENDED FOR FIXATION (NUROLON, ETHIBOND AND SILK). MALPOSITION: MALPOSITION OF A BREAST TISSUE EXPANDER IS DEFINED AS AN INCORRECT PLACEMENT DURING SURGERY OR THE SHIFTING OF THE BREAST TISSUE EXPANDER FROM ITS ORIGINAL POSITION. MALPOSITION HAS REPORTEDLY BEEN A FREQUENT EVENT DUE TO ITS MULTIFACTORIAL CAUSES AND IT CAN BE EXPECTED DURING THE LIFETIME OF THE DEVICE. THE SHIFTING OF THE DEVICE CAN BE PRODUCED BY TRAUMA, CAPSULAR CONTRACTURE, GRAVITY, MISUSE/FAILURE OF THE FIXATION SYSTEM, OR INITIAL WRONG PLACEMENT. THE SURGEON MUST PLAN THE OPERATION CAREFULLY AND CONDUCT THE SURGERY WITH A TECHNIQUE THAT CAN MINIMIZE, BUT NOT COMPLETELY EVADE THE RISK OF MALPOSITION. THE RISK ASSOCIATED WITH THIS EVENT IS DISSATISFACTION WITH AESTHETIC OUTCOMES. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.
THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICITY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. ADDITIONALLY, NO ADVERSE OUTCOME REGARDING THE PATIENT HAS BEEN REPORTED. CLINICALLY, APPARENT ROTATION MORE COMMONLY OCCURS WHEN AN IMPLANT FLIPS BACK TO FRONT THE BACK SURFACE OF THE IMPLANT BECOMES ANTERIOR. PATIENTS WITH THIS PROBLEM USUALLY REPORT SUDDENLY NOTICING A DIFFERENCE IN THE APPEARANCE OF THEIR BREAST(S). (AHMAD & LISTA, 2017) EACH PATIENT SHOULD BE GIVEN THE ESTABLISHMENT LABS "(B)(4) ® TISSUE EXPANDER: INFORMATION FOR THE PATIENT" DOCUMENT DURING HER SURGICAL CONSULTATION. IT IS THE SURGEON'S RESPONSIBILITY TO ENSURE THAT THIS HAPPENS, AND IT IS A REQUIREMENT FOR THE USE OF THE DEVICE. THE PATIENT MUST BE GIVEN ENOUGH TIME TO READ AND COMPLETELY UNDERSTAND THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH TISSUE EXPANDER-BASED BREAST RECONSTRUCTION SURGERY. IN ORDER TO DOCUMENT A SUCCESSFUL INFORMED CONSENT PROCESS, THE PATIENT, A WITNESS, AND THE SURGEON SHOULD SIGN THE "INFORMED CONSENT DOCUMENT," WHICH WILL BE PART OF THE PATIENT'S MEDICAL FILE. THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: USE OF TRUE FIXATION® SYSTEM (TFS) (B)(4) ® TISSUE EXPANDER - TRUE FIXATION® SYSTEM INCLUDES TWO FIXATION TABS, MADE OF REINFORCED SILICONE, WHICH ARE SUTURED TO THE ADJACENT BREAST TISSUE TO PREVENT POSSIBLE ROTATION AND/OR DISPLACEMENT AFTER SURGERY, WITH THE SUBSEQUENT DISTORTION IN THE EXPECTED RESULTS. (B)(4) ® TISSUE EXPANDER TRUE FIXATION® SYSTEM HAS AN OPENING IN EACH TAB TO ALLOW THE SURGEON TO AFFIX THE DEVICE'S TAB TO THE ADJACENT BREAST TISSUE WITH A SINGLE STITCH. CAUTION MUST BE TAKEN IN ORDER NOT TO DAMAGE THE EXPANDER SURFACE DURING THIS MANEUVER; THIS IS ACCOMPLISHED BY RETRACTING THE EXPANDER WHILE THE STITCH IS PLACED IN THE ADJACENT BREAST TISSUE. TO PASS THE SUTURE THROUGH THE OPENING, IT IS NOT NECESSARY TO KEEP THE NEEDLE IN THE SURGICAL AREA. IT IS DONE ONLY BY INSERTING THE SUTURE THROUGH THE HOLE, WITHOUT THE NEEDLE, AND TYING IT, AVOIDING DAMAGE TO THE SURFACE OF THE TISSUE EXPANDER. BRAIDED PERMANENT SUTURE IS RECOMMENDED FOR FIXATION (NUROLON, ETHIBOND AND SILK). MALPOSITION MALPOSITION OF A BREAST TISSUE EXPANDER IS DEFINED AS AN INCORRECT PLACEMENT DURING SURGERY OR THE SHIFTING OF THE BREAST TISSUE EXPANDER FROM ITS ORIGINAL POSITION. MALPOSITION HAS REPORTEDLY BEEN A FREQUENT EVENT DUE TO ITS MULTIFACTORIAL CAUSES AND IT CAN BE EXPECTED DURING THE LIFETIME OF THE DEVICE. THE SHIFTING OF THE DEVICE CAN BE PRODUCED BY TRAUMA, CAPSULAR CONTRACTURE, GRAVITY, MISUSE/FAILURE OF THE FIXATION SYSTEM, OR INITIAL WRONG PLACEMENT. THE SURGEON MUST PLAN THE OPERATION CAREFULLY AND CONDUCT THE SURGERY WITH A TECHNIQUE THAT CAN MINIMIZE, BUT NOT COMPLETELY EVADE THE RISK OF MALPOSITION. THE RISK ASSOCIATED WITH THIS EVENT IS DISSATISFACTION WITH AESTHETIC OUTCOMES. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.
AN ADVERSE EVENT WAS REPORTED IN A PATIENT IN CLINICAL STUDY (B)(4) ® ABR. THE SUBJECT UNDERWENT A BILATERAL MASTECTOMY ON (B)(6) 2023 AND HAD A TISSUE EXPANDER PLACED IN EACH BREAST. ON 09-JAN-2024 (21-DAY FOLLOW-UP VISIT) A ROTATION OF THE EXPANDER PLACED IN THE RIGHT BREAST WAS DISCOVERED, SO IT WAS DECIDED NOT TO PERFORM THE EXPANSION PROCESS IN EITHER BREAST DURING THAT VISIT. ON (B)(6) 2024, A REVISION INTERVENTION WITH A SHORT PERIOD OF ANESTHESIA WAS EXECUTED AND DURING THE SURGERY IT WAS CONFIRMED THAT THE SUTURE HAD COME LOOSE FROM THE TISSUE AND NOT FROM THE FIXATION TABS OF THE EXPANDER. THE AIM OF THE SURGERY WAS ACHIEVED, AND THE EXPANDER WAS PLACED AND FIXED IN THE CORRECT POSITION THROUGH AN INFRAMAMMARY INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62461 | MOTIVA FLORA TISSUE EXPANDER | MOTIVA FLORA TISSUE EXPANDER | LCJ | MOTIVA USA LLC | 23092095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |