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

Catalog Number	3341455
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	11/25/2016
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: left side rupture.Concomitant products: right: cat#: 3341455; s/n: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) african american, white & native american female patient underwent revision breast reconstruction surgery with a 585cc mentor memoryshape breast implant.The patient reported left side disfigured chest and uncomfortable feeling.On (b)(6) 2016, ultrasound was performed.The physician stated that the implant was completely ruptured.As a result, patient underwent bilateral explantation and replacement on (b)(6) 2019 with catalog number shpx700 ; serial number (b)(4) on the left side and catalog number shpx700; serial number (b)(4) on the right side.
Additional Manufacturer Narrative
On 5/10/2019, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019; mentor became aware that patient was also presented with bilateral capsular contracture; baker grade unknown in addition to left side rupture.This report is for patient's left side.The right side is being submitted in a separate report.On 6/7/2019; device evaluation was completed: 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.During evaluation of the sample it was observed a tear measuring approximately 33 cm running from the anterior aspect to the posterior.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were discovered.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma,excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.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 condition has also been associated with device deflation/ rupture, wrinkling and/or displacement of the prosthesis.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.The reported complaint was confirmed.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: 8600921
• Report Number: 1645337-2019-11439
• Device Sequence Number: 2180301
• Product Code: FTR
• UDI-Device Identifier: 00081317005377
• UDI-Public: 00081317005377
• Combination Product (Y/N): N
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2019

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: 10/08/2019
• Device Catalogue Number: 3341455
• Device Lot Number: 6867570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 05/22/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 05/16/2019; 06/19/2019
• 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: 27 YR