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

Model Number	3542007
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/04/2020
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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation revision with a mentor memorygel breast implant 200cc and experienced deflation on the left side postoperatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.The expiration date for the reported lot number is prior to the implantation date.Per ifu, devices are not to be implanted after sterility expiration date.This is an off-label use of the device.If additional information is received regarding the lot number or implantation date, a supplemental report will be submitted.
Additional Manufacturer Narrative
On (b)(6) 2020, additional information was received indicating the patient underwent device removal on (b)(6) 2020.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On sep 22 2020, the mentor failure analysis lab received a device (lot number 7298893) 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.On sep 23 2020, it was confirmed that the device returned was the complaint device (saline mentor smooth round moderate profile 325cc, catalog number 3501650, serial number (b)(6)).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.The implantation date was prior to the expiration date for this lot number.The device was not used in an off-label manner.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during visual evaluation, an anomaly was observed on the device consistent with a crease/fold in the posterior aspect and extending to the anterior view.A tear was also observed within the crease/fold in the posterior view, measuring approximately 0.5 cm.The evaluation determined that the loss of shell integrity is consistent with a crease fold deflation of the implant shell, which is a known inherent risk of saline-filled mammary prosthesis.Deflation 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 deflation at a later time.Breast implants may also simply wear out over time.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.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 SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10102296
• Report Number: 1645337-2020-06666
• Device Sequence Number: 19657609
• Product Code: FWM
• UDI-Device Identifier: 00081317000631
• UDI-Public: 00081317000631
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/04/2020

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: 02/28/2020
• Device Model Number: 3542007
• Device Catalogue Number: 3501650
• Device Lot Number: 7298893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 08/10/2020; 09/22/2020; 10/20/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 08/20/2020; 10/06/2020; 10/21/2020
• 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: Other; Required Intervention
• Patient Age: 79 YR