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

Model Number	3542001
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2020
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: rupture.(b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent breast augmentation revision surgery with two 200cc mentor memorygel breast implants experienced bilateral rupture post procedure.As a result, patient had an explantation (b)(6) 2020.This medwatch form is for product a.
Additional Manufacturer Narrative
The investigation of the pictured device was completed by the failure analysis lab on 10/13/2020.Device evaluation summary: according to the information reported, a deflation occurred in a tissue expander.During the visual evaluation of the device, no apparent damage or anomalies were observed.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
It was discovered on (b)(6) 2020, that is ' is report source user facility checked' was erroneously submitted in initial.Correction 'is report source distributor' should be checked.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2020, the mentor failure analysis lab has received the device for evaluation.The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2020.Device evaluation summary: according to the information received, the patient experienced a rupture in the left breast implant.During the visual evaluation of the product, parallel lines of shell wear were observed on the posterior aspect.Within the shell wear, a tear was observed measuring approximately 2.5 cm.The evaluation determined that the loss of shell integrity is consistent with a rupture caused by wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.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: 10386013
• Report Number: 1645337-2020-09829
• Device Sequence Number: 2391278
• Product Code: FTR
• UDI-Device Identifier: 00081317000822
• UDI-Public: 00081317000822
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2020

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: 06/30/2016
• Device Model Number: 3542001
• Device Catalogue Number: 3542001
• Device Lot Number: 6482153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 07/19/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 10/15/2020; 10/22/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/11/2020; 10/15/2020; 11/10/2020
• 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: 38 YR