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

Model Number	3501480
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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 for lot #230769 and for lot #225401, 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: breast prosthesis deflation.Explant date: explantation month, day, and year: (b)(6) 2021.(b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision procedure with a mentor smooth round spectrum 475cc saline breast prosthesis that deflated after implantation.The deflation was diagnosed via a physical exam.As a result, the patient is scheduled to undergo bilateral explantation and replacement with unspecified mentor gel breast prostheses on (b)(6) 2021.Two lot numbers were reported for this event: lot #230769 for left breast prosthesis and lot #225401 for right breast prosthesis.It was not specified which side deflated.If clarification is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
On 13-oct-2021, the mentor failure analysis lab received the device for evaluation.Mentor also received additional information that stated that the patient¿s replacement breast prostheses are mentor memorygel breast implant 560cc gel breast prostheses.On 21-oct-2021, mentor received additional information about the event.It was reported that both of the patient¿s breast prostheses deflated post implantation.This medwatch report will be used to report the patient¿s right breast prosthesis (lot #225401).A separate medwatch report will be submitted for the left breast prosthesis deflation.On 28-oct-2021, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak test, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and two tears (a and b) were noted on the anterior view, measuring less than 0.1 cm.Microscopic examination was performed on the edges of both ruptures, and parallel striations were found in the whole area of both tears.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 12356997
• Report Number: 1645337-2021-09452
• Device Sequence Number: 11737767
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: 00081317002024
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 04/30/2005
• Device Model Number: 3501480
• Device Catalogue Number: 3501480
• Device Lot Number: 225401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2001
• 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
• Patient Sex: Female