MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem No Apparent Adverse Event (3189)

Patient Problem Necrosis Of Flap Tissue (1972)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Article citation: ¿refinements in the techniques of 2-stage breast reconstruction,¿ matthew d.Freeman, bs, rahul vemula, md, rahul rao, ma, tim s.Matatov, md, amy l.Strong, phd, mph, ravi tandon, md, abigail e.Chaffin, md, and david a.Jansen, md, facs, annals of plastic surgery, vol.76, supplement 4, june 2016, pp.S304-s311.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the senior author, dr.David a.Jansen, regarding the number of allergan devices used in the study, the causality of the reported adverse events, product information, date of explant surgery, name of explant surgeon, and if the explanted devices will be returned was requested.No additional information will be provided as further follow up is not possible as the doctor is unavailable for additional questioning.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 Description

Reported events of 12 cases of "mastectomy skin flap necrosis" for patients implanted with tissue expanders only were found within the journal article "refinements in the techniques of 2-stage breast reconstruction", annals of plastic surgery, vol.76, supplement 4, 2016, pp.S304-s311.The article defines "mastectomy skin flap necrosis" as necrosis "that was deemed serious enough for operative debridement." the authors indicated that the patient's tissue expanders were "allergan and mentor." the author did not explicitly state how many patients were implanted with either an allergan or a mentor device."operative debridement" was provided as treatment.As most patients within the article had devices explanted, the devices are assumed explanted.The manufacturer is unknown.The affected side was not provided.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5928609
• MDR Text Key: 53938811
• Report Number: 9617229-2016-00118
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR