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

Model Number	3507100BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: rupture.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female who underwent primary breast augmentation with a mentor memorygel 100cc silicone prosthesis experienced right sided rupture post procedure.Mri, and physical examination was performed by a physician and rupture was diagnosed.As a result, an explant was performed on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 2020 mentor became aware that unintentionally missed selecting b1, and b2 in initial report.Please see the correct selection in this report.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2020: during a visual evaluation, an anomaly was observed on the device consistent with a crease/fold in the anterior view.Leak testing was performed, according with mentor procedure, and it revealed a tear within the crease measuring approximately 0.1 cm.The evaluation determined that the loss of shell integrity is consistent with a crease fold rupture of the implant shell, which is a known inherent risk of gel-filled mammary prosthesis.Rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a rupture in a later time.Breast implants may also simply wear out over time.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10741703
• Report Number: 1645337-2020-13706
• Device Sequence Number: 3125126
• Product Code: FTR
• UDI-Device Identifier: 00081317000013
• UDI-Public: 00081317000013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2020

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: 01/31/2005
• Device Model Number: 3507100BC
• Device Catalogue Number: 3507100BC
• Device Lot Number: 205628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/01/2020; 11/17/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/06/2020; 11/18/2020
• 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: 43 YR