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

Catalog Number	UNK TISSUE EXPANDER
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article citation: ¿direct hospital cost of outcome pathways in implant-based reconstruction with acellular dermal matrices,¿ ali a.Qureshi, md, kristen broderick, md, susan funk, mba, nancy reaven, mba, marissa m.Tenenbaum, md, and terence m.Myckatyn, md, facs, frcsc, prs global open, 2016 pp.1-6.The reported event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The allegation of contaminated implants cannot be investigated by analysis of the device as the device is not available for return to allergan.Follow up with the author returned that no information was available and further follow up is not possible.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.The stresses of the expanding device may induce pressure ischemia and necrosis, especially in tight or thin-skinned areas.Folds in a partially filled tissue expander may also result in thinning and erosion of adjacent tissue.Excessively rapid tissue expansion may compromise the vascularity of the overlying tissue.
Event or Problem Description
Reported events of 6% of 265 patients implanted with allergan tissue expanders and acellular dermal matrix (adm) alloderm rtm that experienced ¿necrosis without dehiscence.¿ the event was found within the journal article, ¿direct hospital cost of outcome pathways in implant-based reconstruction with acellular dermal matrices,¿ in prs global open, 2016 pp.1-6.The authors indicated that all patients were implanted with ¿textured allergan ((b)(4)) 133mv devices.¿ it is unknown if treatment was provided.The affected side was not provided.As the study was noted to survey ¿two-stage expander reconstruction¿, it is assumed that the devices were explanted.

• Brand Name: UNK TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6022809
• Report Number: 9617229-2016-00158
• Device Sequence Number: 15093235
• Product Code: LCJ
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2016
• Initial Report FDA Received Date: 10/12/2016
• 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: ACELLULAR DERMAL MATRIX (ADM) ALLODERM RTM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR