MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number N-67-133P-MV13

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Reporting facility to ansm: (b)(6).Address: (b)(6).Reporter contact: (b)(6).Telephone: (b)(6).Fax: (b)(6).Email: (b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.The event of lymphoma-alcl is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: lymphoma-alcl, event was diagnosed after device was explanted, original source cause not determined.

Event Description

Healthcare professional reported ductal carcinoma in site of right breast.Histopathological markers cd30+ and alk- have been provided for device that followed.Lymphoma-alcl being captured in this record as original source cause of the event cannot be determined.Device has been explanted.

Manufacturer Narrative

Previous medwatch submission noted lymphoma-alcl and seroma-late.Upon review, the tissue expander was removed before the diagnosis of alcl, which is found in (b)(4) under mrn 9617229-2023-10504.The reported events of seroma (date of occurrence 2021) and lymphoma-alcl (confirmed 2022) relate to the style 410 allergan captured by (b)(4).Allergan medical safety determined that there is no malignancy.¿ additional, corrected and/or changed data.

Event Description

Previous medwatch submission noted lymphoma-alcl and seroma-late.Upon review, the tissue expander was removed before the diagnosis of alcl, which is found in (b)(4) under mrn 9617229-2023-10504.The reported events of seroma (date of occurrence 2021) and lymphoma-alcl (confirmed 2022) relate to the style 410 allergan captured by (b)(4).Allergan medical safety determined that there is no malignancy.¿.

• Brand Name: STYLE 133PLUS MV TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17188059
• MDR Text Key: 317719490
• Report Number: 9617229-2023-10503
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 05060263395362
• UDI-Public: 5060263395362
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Catalogue Number: N-67-133P-MV13
• Device Lot Number: 3067228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female