MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542515
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.The device history record (dhr) 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction primary with a mentor siltex contour profile spectrum 650cc and experienced deflation of the left breast tissue expander.As a result, the patient had undergone explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On 2/20/19, device evaluation and investigation findings: upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.Mentor product analysis lab discovered a rent measuring approximately 0.4 cm within a line of shell wear, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.A manufacturing record evaluation (mre) of lot number 5934738 was reviewed and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.There is no evidence that the issue is related with manufacturing.Because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8264446
• Report Number: 1645337-2019-08017
• Device Sequence Number: 1500985
• Product Code: FWM
• UDI-Device Identifier: 00081317002178
• UDI-Public: 00081317002178
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 09/08/2013
• Device Catalogue Number: 3542515
• Device Lot Number: 5934738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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: 54 YR