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

Model Number	3545270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	05/02/2019
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: bilateral capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation with mentor memorygel breast implant 270cc gel breast prostheses developed baker grade ii capsular contracture in both breasts.Bilateral capsular contracture was confirmed by a healthcare professional.As a result, the patient underwent bilateral explantation on (b)(6) 2019.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 12-mar-2021, the mentor failure analysis lab 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.In addition, mentor received additional information about the suspect medical device.It is a mentor memorygel breast implant 270cc gel breast prosthesis, catalog #354-5270, lot #7324717.The manufacturer for this device is mentor medical systems b.V.Mentor medical systems b.V, located in leiden, the netherlands, is a foreign manufacturer of medical devices that are not cleared or approved for sale in the us.It is a separate legal entity from mentor texas.Per 21 cfr 803.58 and "medical device reporting for manufacturers" (fda guidance document issued on november 8, 2016), we are ¿not required to submit mdr reports for events occurring in other countries for a device that is manufactured in a foreign country and that is not cleared or approved for marketing in the us.However, if mentor becomes aware of information that reasonably suggests a device has malfunctioned and that a similar device that is marketed in the us would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, then mentor should report the device malfunction that occurred outside the us." since mentor medical systems b.V.Do not market any devices in the us, manufacture & market all their devices outside the us, and have never held fda approval nor clearance for any of their products, their devices do not meet the criteria for mdr reportability.However, as this event was already reported, mentor will continue reporting all additional information received with a supplemental report if necessary.G1 manufacturer contact phone number: (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 05-apr-2021, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient developed capsular contracture.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Mentor concluded that the capsular contracture in the patient¿s breast was the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.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 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: 9324752
• Report Number: 1645337-2019-23876
• Device Sequence Number: 19430222
• Product Code: FTR
• UDI-Device Identifier: 00081317007098
• UDI-Public: 00081317007098
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 05/10/2021
• Device Model Number: 3545270
• Device Catalogue Number: 354-5270
• Device Lot Number: 7324717
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 03/12/2021; 04/05/2021
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 03/30/2021; 04/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR