MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER 100CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	3504301M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.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.Initial reporter phone number: (b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified procedure with a mentor 100cc tissue expander that deflated intraoperatively.As a result, the device was replaced with a mentor tissue expander 400cc, catalog number 3504303m, serial number (b)(4), lot number 7359417.No patient consequences were reported.
Additional Manufacturer Narrative
On 5/31/2019, the mentor failure analysis lab received the device for evaluation.Device evaluation summary: during evaluation of the sample it was to be intact.In addition during the leak test a rupture was noted in the anterior view measuring less than 0.1 cm.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Deflation is a known complication associated with mentor mammary prostheses.Possible causes of deflation of saline-filled implants include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, manual massage, and intimate physical contact; stress or trauma to the breast, mechanical damage prior to or during surgery, compression during mammographic imaging.Although no conclusion could be reach on the reported event, it should be noted that mentor performs 100% inspection of all devices prior to release.Please note that it is possible to damage the implant during insertion.Ensure that excessive force is not applied to a very small area of the shell during insertion of the device through the incision.Instead, apply force over as large an area of the implant as possible when inserting it.Avoid pushing the device into place with one or two fingers in a localized area, as this may create an area of weakness on the shell.In addition, an incision should be of appropriate length to accommodate the style, size, and profile of the implant.This will reduce the potential for creating excessive stress to the implant during insertion, and will avoid the risk of damage to the implant.Manufacturer reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER 100CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8450088
• Report Number: 1645337-2019-09664
• Device Sequence Number: 429344
• Product Code: LCJ
• UDI-Device Identifier: 00081317002376
• UDI-Public: 00081317002376
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: 3504301M
• Device Lot Number: 7628784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/25/2019
• Patient Sequence Number: 1