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

Model Number	3542514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Code Available (3191); Cancer (3262)
Date of Event	08/31/2020
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: neoplasm malignant.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent primary breast reconstruction surgery with mentor siltex contour profile spectrum implants (spec siltex contour 550cc, date of implantation (b)(6) /2010) secondary to left-sided invasive lobular carcinoma experienced a recent diagnosis of left sided metastatic disease (left breast cancer recurrence which spread to the left axilla and skin).In 2010, the patient was diagnosed with left breast cancer and received chemotherapy.Subsequently, she underwent a bilateral simple mastectomy with sentinel lymph node mapping on (b)(6) 2010 with immediate reconstruction using alloderm and placement of the mentor siltex contour profile spectrum implants bilaterally.On (b)(6) 2020, the patient underwent an mri.The mri displayed the left breast malignancy which corresponds to a spiculated mass.The patient has now undergone bilateral removal of implants and capsulectomies as a result of this cancer recurrence, as well as a bia-alcl diagnosis on the contralateral side (reference manufacturer's report number 1645337-2020-13475).The explant took place on (b)(6) 2020, and the patient did not receive replacements.This report relates to the left prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2020 mentor became aware that this complaint has been reported to the fda by the patient under report number:mw509669, therefore section e4 updated to" yes".This report relates to the left prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 25, 2020 mentor became aware of data submitted in the previous report that requires correction.It was inadvertently stated that the patient submitted the event directly to the fda, but it was the operating physician.Additionally, the patient was hospitalized for an unspecified reason/timeframe, but this was omitted.Manufacturer¿s reference number (b)(4).Updated hospitalization initial/prolonged from blank to checked.
Additional Manufacturer Narrative
On january 4, 2021 mentor became aware that previous supplements:(2) unintentionally missed reporting that the event report updated.Manufacturer¿s reference number: (b)(4) august 31, 2020.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10757729
• Report Number: 1645337-2020-13478
• Device Sequence Number: 3385403
• Product Code: FWM
• UDI-Device Identifier: 00081317002161
• UDI-Public: 00081317002161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2020

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: 06/30/2014
• Device Model Number: 3542514
• Device Catalogue Number: 3542514
• Device Lot Number: 5999583
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 11/25/2020; 01/04/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/12/2020; 01/04/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 73