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

Catalog Number	UNK TISSUE EXPANDER
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971); Seroma (2069)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Cited article reports: all patients, who underwent a mastectomy followed by immediate one- or two-stage ibbr were included.The primary outcome measure was explantation of the ¿tissue expander¿ (te) and/ or implants within 60 days after breast reconstruction.Secondary outcomes were overall complication rate and secondary corrections.One- and two-stage ibbr showed a comparable explantation and complication rate in our retrospective study.In one-stage ibbr more secondary corrections were detected.The data were retrospectively collected.Complications included: infection, necrosis of skin or nipple, bleeding, te/implant deflation or rupture, positive tumour margins after mastectomy (requiring reoperation), and seroma.Another secondary outcome was secondary correction(s) of one of the breasts to improve cosmetic results within the first year after breast reconstruction.Secondary corrections were: lipofilling to improve breast contour, capsulectomy with or without change of implant, mastopexy or augmentation of the contralateral breast, recontouring of the reconstructed breast by surgical correction, correction of scars and ¿dogear¿ correction.From all patients, 48 patients underwent an explantation of a te or implant.Eleven patients underwent an ex-plantation of an implant in a one-stage ibbr group, and 37 patients in the two-stage ibbr.In two-stage ibbr, 26 tes were removed before the planned second-stage procedure and 13 definitive implants were removed.In two patients , both te and implant were removed.In the whole analysed population, two main causes for explantation were flap necrosis (11 patients) and infection (32 patients).In five other patients, bleeding, wound dehiscence, and incorrect size of the initial implant were indications for explantation of the te/ implant.
Additional Manufacturer Narrative
(b)(4).Article citation: cjim thuenissen, rm brohet, y hu, jh van uchelen, jhc mensen, al van rijssenv, "risk of breast implant removal after one versus two-stage breast reconstructive surgery" , journal of plastic, reconstructive & aesthetic surgery, https://doi.Org/10.1016/j.Bjps.2021.11.112, 30-dec-2021.The events of seroma, infection, necrosis and wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: "infection" , "necrosis of skin or nipple, bleeding" , "tissue expander/implant deflation or rupture ","seroma", "secondary corrections of one of the breasts to improve cosmetic results within the first year after breast reconstruction, wound dehiscence" and "positive tumor margins after mastectomy (requiring reoperation)".

• Brand Name: UNK TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13315229
• Report Number: 9617229-2022-01239
• Device Sequence Number: 10080174
• Product Code: LCJ
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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 Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female