MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT

Catalog Number	3341352G
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Swollen Lymph Nodes (2093); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) review is in progress.Once completed, the information will be submitted in a supplemental.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a female patient of unknown age who underwent breast prothesis implantation with mentor siltex memoryshape medium height, high projection gel implants on (b)(6) 2011 (catalog #3341352g, serial #(b)(4) ) has been diagnosed with bia-alcl in (b)(6) 2017.The patient also reported left breast implant rupture, free silicone in her chest area and enlarged lymphnodes.The patient is still implanted but planned course of treatment is explantation with mentor replacement.She is unsure what other treatments, such as chemotherapy or radiation, would be required.Multiple attempts have been made to obtain more information regarding this complaint, however, no further information has been made available.
Additional Manufacturer Narrative
The device history record (dhr) of lot number 6008186 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
On (b)(6) 2015, the patient reported she has a left implant rupture that was diagnosed in (b)(6) 2017 and that she has not yet undergone explantation because she would like to be tested for bia-alcl due to the fluid in her left implant that was noted on us.The patient reported that she is scheduling on consultation at md anderson cancer center with dr.(b)(6) to get tested for bia-alcl in the near future, however, no date has been scheduled thus far.The patient did not have a bia-alcl diagnosis in the past and does not currently have a diagnosis of bia-alcl now.The patient also reported bilateral baker grade iv capsular contracture, left implant device migration outside of the pocket and shape distortion and hard/swollen left side lymph nodes.The patient also reported headaches, kidney problems, elevated labs (platelets, wbcs, mcv, mpv), and other issues.Patient will schedule explantation and treatment based on results of testing she will complete with md anderson.This report is for the patient¿s left-sided device.Right side is being reported in a separate report.Manufacturer's ref no: (b)(4).
Additional Manufacturer Narrative
On 10/21/2019, mentor became aware that date of explantation was (b)(6) 2019.Hence, following has been updated (b)(4).This supplemental report is for the patient¿s left-sided device.Manufacturer's ref no: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6863086
• Report Number: 1645337-2017-00104
• Device Sequence Number: 590596
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2017

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 Catalogue Number: 3341352G
• Device Lot Number: 6008186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 08/16/2017; 09/03/2019; 10/21/2019
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 09/22/2017; 09/26/2019; 11/05/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 54 YR