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

Catalog Number	SHPX200
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	07/29/2019
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 (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: capsular contracture baker grade 3 or 4.Concomitant medical products: 200cc mentor memorygel breast implant, catalog # shpx-200, serial # (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with a 200cc mentor memorygel breast implant and experienced postoperative left-sided capsular contracture (baker grade 3 or 4).Capsular contracture was diagnosed in office.As a result, the patient underwent explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor received the suspect medical device.On (b)(6) 2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, it was reported that the patient developed capsular contracture.During evaluation of the sample it was observed to be intact.No anomalies were observed.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.¿ an investigation of the returned device was performed, and mentor could not uncover a device failure that we could connect to the reported medical symptoms, however complaint information will be included in complaint trending that is reviewed by quality assurance 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: 8931549
• Report Number: 1645337-2019-17633
• Device Sequence Number: 13516516
• Product Code: FTR
• UDI-Device Identifier: 00081317025207
• UDI-Public: 00081317025207
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: Health Professional
• Device Expiration Date: 06/10/2023
• Device Catalogue Number: SHPX200
• Device Lot Number: 7595328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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: 66 YR