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

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Article citation: "prepectoral implant-based breast reconstruction with post-mastectomy radiation," by valerie lemaine, md, mph, sarah m.Elswick, md, christin a.Harless, md, sarah n.Bishop, md, cathy d.Schleck, bs, jay mandrekar, ph.D, ryan d.Reusche, md, robert w.Mutter, md, judy c.Boughey, md, steven r.Jacobson, md and published in plastic and reconstructive surgery advance online on 26/mar/2018.(b)(4).The events of infection, necrosis, capsular contracture, and wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: 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.Hematoma/seroma: postoperative hematoma and seroma may contribute to infection.Postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly by postoperative use of closed drains.Persistent, excessive bleeding must be controlled before the device is implanted.Capsular contracture: formation of a fibrous tissue capsule around an implanted device is a normal physiological response, although not all capsules contract.Contracture of the fibrous capsular tissue surrounding the breast tissue expander may cause a range of symptoms including firmness, discomfort, pain, distortion, palpability, and/or displacement.Contracture may make expansion difficult and painful.Tissue damage: improper patient selection, tissue expander selection, placement and inflation may result in tissue damage and require premature explantation of the tissue expander.Signs of tissue damage include abnormal skin pallor (e.G., blanching), erythema, edema, pain, or tenderness, and should be promptly investigated.In the absence of other signs, some temporary erythema may occur, and is a recognized normal tissue response to expansion.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.Tissue viability may be adversely affected by radiotherapy, steroid use or other drug therapy in the surgical pocket, excessive heat or cold therapy, and smoking.

Event Description

Reviewed and attached journal article "prepectoral implant-based breast reconstruction with post-mastectomy radiation." per the journal article the events of "surgical site infection, mastectomy skin flap necrosis, hematoma, capsular contracture, seroma, and wound dehisicence" were reported against an unknown manufacturer tissue expander.

• 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: 7648073
• MDR Text Key: 112700898
• Report Number: 9617229-2018-05021
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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