MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE MODERATE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
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 performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: capsular contracture.(b)(6).(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported via medwatch form 070028-2020-01 that a (b)(6) caucasian female patient underwent a breast reconstruction primary with mentor siltex contour profile moderate 425cc and experienced deflation on the left breast implant and bilateral capsular contracture.The patient experienced diastasis recti.The patient had a history of breast carcinoma, bilateral mastectomies.As a result, the patient had undergone removal and replacement with mentor breast implant of unknown type on (b)(6) 2019.
Additional Manufacturer Narrative
On 2/25/2020, the mentor failure analysis lab has received the device for evaluation.On 3/2/2020, during visual evaluation of the device it was observed to be ruptured.The evaluation determined that the rupture was caused by the stress occasioned to the shell by the capsular contracture.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.¿ an investigation of the returned device was performed, and mentor could not uncover any device failure that we could connect to the reported medical symptoms, however complaint information will be included in complaint trending that is reviewed by quality assurance to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9617886
• Report Number: 1645337-2020-01118
• Device Sequence Number: 2738944
• Product Code: FWM
• UDI-Device Identifier: 00081317001881
• UDI-Public: 00081317001881
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2020

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 Expiration Date: 04/17/2010
• Device Model Number: 3542914
• Device Catalogue Number: 3542914
• Device Lot Number: 5677103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: 55 YR
• Patient Weight: 73