MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3505305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a reconstructive skin surgery on the thigh using two expanders with a mentor tissue expander 250cc and the patient experienced pain and one of the devices leaked.As a result, the patient underwent removal and replacement of both implants with mentor tissue expanders 150cc, catalog number 3505304m, lot number 7381670, serial number (b)(4) on (b)(6) 2019.
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained clear fluid.White material was observed within the device and no foreign material on the shell surface.During initial evaluation a crease was observed on the anterior aspect.Leak testing was performed according with mentor procedures and it revealed a rupture within crease on the anterior aspect, measurement approximately 0.4 cm.No other anomalies were observed.Deflation complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rent within a crease was found on the device.These findings are consistent with a crease/fold failure which is a known inherent risk associated with the use of saline-filled mammary prostheses and may be the result of one or more of the following contributing factors: underinflation or overinflation of the device, continuous and sustained stresses to the device - such as capsular contracture or too small a breast pocket and folding or wrinkling of the shell in the breast pocket.There is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Pain is a known complication associated with these devices and is referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
In the supplemental report submitted on 5/7/2019, the device was erroneously labeled a mammary prosthesis in the device evaluation summary.The device was tissue expander used in the thigh.Updated device evaluation summary: during evaluation of the sample, a crease was observed on the anterior aspect.Leak testing revealed a rupture within the crease, measuring approximately 0.4 cm.No other anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.These kind of findings are consistent with a crease/fold failure which is a known inherent risk associated with the use of these devices and may be the result of one or more of the following contributing factors: underinflation or overinflation of the device, continuous and sustained stresses to the device.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8462414
• Report Number: 1645337-2019-09783
• Device Sequence Number: 3013395
• Product Code: LCJ
• UDI-Device Identifier: 00081317002581
• UDI-Public: 00081317002581
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 3505305M
• Device Lot Number: 7626136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 07/24/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/07/2019; 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR