MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3541708
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994)
Date of Event	08/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: as of now there is no information regarding the explant or reoperation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old hispanic female patient underwent primary breast reconstruction surgery with 775cc mentor memoryshape breast implant on both sides and experienced bilateral implant rupture and bilateral breast pain postoperatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the patient experienced bilateral capsular contracture; baker grade iv, and date of surgery is (b)(6) 2021.Hence, following fields have been updated on this form: is required intervention has been selected under section b; field b2 fields d6b for explantation date is (b)(6) 2021.Field h6 health effect - clinical code is updated to capsular contracture.Field h6 health effect - impact code ¿device explantation¿ has been added.Field h6 type of investigation has been updated to "device not returned".Reason for device explant and/or reoperation: right rupture and capsular contracture; baker grade iv this supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 5, 2021, mentor became aware that the date of surgery was postponed and a new surgery date has not been scheduled yet.Hence, following fields have been updated on this form: is required intervention has been de-selected under section b; field b2.Fields d6b for explantation date - date has been removed.Field h6 health effect - impact code ¿recognized procedural complication¿ has been added.Field h6 type of investigation has been updated to "device not accessible for testing".Reason for device explant and/or reoperation: as of now there is no information regarding the explant or reoperation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.This supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 26, 2021, mentor became aware that the date of surgery was (b)(6) 2021.Hence, following fields have been updated on this form: - is required intervention has been selected under section b; field b2 - fields d6b for explantation date is (b)(6) 2021 -field h6 health effect - impact code ¿device explantation¿ has been added - field h6 type of investigation has been updated to "device not returned" reason for device explant and/or reoperation: right rupture and capsular contracture; baker grade iv this supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab received the device for evaluation.On (b)(6) 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample determined that the mentor memoryshape¿ mm 775cc breast implant was found to have a tear on the posterior view measuring approximately 19.8 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the posterior view, measuring approximately 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsules, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 22, 2021, mentor became aware that patient received 800cc devices as replacement on (b)(6) 2021.This supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11014300
• Report Number: 1645337-2020-15916
• Device Sequence Number: 17267232
• Product Code: FTR
• UDI-Device Identifier: 00081317005537
• UDI-Public: 00081317005537
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 3541708
• Device Catalogue Number: 3541708
• Device Lot Number: 6752626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 06/07/2021; 08/05/2021; 10/26/2021; 11/08/2021; 11/22/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 06/15/2021; 08/10/2021; 11/02/2021; 11/15/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic