MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133FX TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	133FX-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Infection: pre-existing infections not resolved before tissue expander placement may increase the risk of periprosthetic infection.Infection is an inherent risk following any type of invasive surgery, and may occur during the tissue expansion process.Patients who present with wound dehiscence, tissue erosion, ischemia or necrosis, and patients undergoing immediate breast reconstruction run an increased risk of periprosthetic infection.Signs of acute infection reported in association with tissue expanders include erythema, tenderness, fluid accumulation, pain and fever.Erythema may also occur as a normal response to expansion.Aspiration to differentiate between this type of erythema and erythema as a sign of early infection is a recognized precaution.Research identifies staphylococcus and pseudomonas organisms in association with infection around tissue expanders.Escherichia and streptococcus organisms have also been noted in association with tissue expanders in the lower extremities.Infection may occur at any time after surgery, and may compromise the expansion process.Capsular contracture may be related to infection in the area surrounding the implant.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature breast tissue expander removal.In rare instances, acute infection may occur in a breast with implants.The signs of acute infection include erythema, tenderness, fluid accumulation, pain, and fever.Very rarely, toxic shock syndrome, a potentially life- threatening condition, has been reported in women after breast implant surgery.It is characterized by symptoms that occur suddenly and include high fever (102°f, 38.8°c or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should be advised to contact a physician immediately for diagnosis and treatment for any of these symptoms.
Event or Problem Description
Healthcare professional reported red breast and infection of an unknown side.This record is for the right side.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified brown particles outer surface the device, opening, crease flat, missing (0-25%).Leak test was performed and found opening on anterior side.A microscopic analysis was performed which identified a broken shell striated edge, consistent in the use of some surgical tool.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: broken shell striated edge due to surgical damage.
Event or Problem Description
Healthcare professional reported red breast and infection of an unknown side.This record is for the right side.Device has been explanted.

• Brand Name: STYLE 133FX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6996970
• Report Number: 9617229-2017-04097
• Device Sequence Number: 1851010
• Product Code: LCJ
• UDI-Device Identifier: 10888628004009
• UDI-Public: (01)10888628004009(10)3012062(11)170126(17)201226
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2020
• Device Model Number: 133FX-13
• Device Catalogue Number: 133FX-13
• Device Lot Number: 3012062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLODERM
• Outcome Attributed to Adverse Event: Required Intervention