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

Catalog Number	3507150BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2019
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: rupture.Concomitant products: 150cc smooth round moderate profile mentor memorygel breast implants catalog: 3507150bc lot: 5863950 sn: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female who underwent breast augmentation revision surgery with two 150cc mentor smooth round moderate profile memorygel breast implants experienced left sided rupture post procedure.A magnetic resonance imagery was performed in (b)(6) 2019 which confirmed left side breast rupture.As a result, the patient had an explantation on (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 9/6/2019.Device evaluation summary: according with the information it was reported that during the procedure the prosthesis was broken.A manufacturing record evaluation (mre) was performed for the finished device number 5863950, and no non-conformances related to the reported complaint were identified.During evaluation of the sample it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No anomalies were observed.The second product received is a concomitant device, no further analysis is required.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.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: 8897674
• Report Number: 1645337-2019-17069
• Device Sequence Number: 1504912
• Product Code: FTR
• UDI-Device Identifier: 00081317000037
• UDI-Public: 00081317000037
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 11/13/2013
• Device Catalogue Number: 3507150BC
• Device Lot Number: 5863950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/14/2019
• 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: Required Intervention
• Patient Age: 60 YR