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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT

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MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT Back to Search Results
Catalog Number 3341507
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/10/2017
Event Type  Injury  
Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.    since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) of lot number 6871997 was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

 
Event Description

It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient¿s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal.

 
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Brand NameMENTOR MEMORYSHAPE BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6847224
Report Number1645337-2017-00103
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3341507
Device LOT Number6871997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/06/2017 Patient Sequence Number: 1
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