MAUDE Adverse Event Report: MENTOR TEXAS SALINE MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501430
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/06/2019
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: deflation.Concomitant products: saline mentor smooth round moderate profile 350cc, catalog 3501655, sn (b)(4), lot 7638937.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 saline mentor smooth round spectrum 225 cc and experienced deflation on the left breast implant.As a result, the patient had undergone removal on (b)(6) 2019.
Additional Manufacturer Narrative
On 10/31/2019, during evaluation of the sample it appeared intact.Leak testing revealed a tear within a crease on the posterior view; the tear measured approximately less than 0.1 cm.No other anomalies were observed.These kind of findings are consistent with a crease/fold failure which is a known inherent risk associated with the use of saline-filled mammary prostheses and may be the result of one or more of the following contributing factors: underinflation or overinflation of the device, continuous and sustained stresses to the device - such as or too small a breast pocket and folding or wrinkling of the shell in the breast pocket.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, it was reported to mentor that the date of surgery was (b)(6) 2019.Patient¿s date of birth was (b)(6) 1968.The patient was 50 years-old at the time of the event.The patient had a history of poland syndrome on the right.The replacement breast implants were unspecified silicone breast implants.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 9/19/2019, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 9/25/2019, it was reported to mentor that the replacement implants were mentor memorygel breast implant 325cc on the right breast implant and mentor memorygel breast implant 200cc on the left breast implant.Manufacturer¿s reference number: (b)(4).

• Brand Name: SALINE MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8761027
• Report Number: 1645337-2019-14873
• Device Sequence Number: 19474297
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/12/2019

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: 12/31/2017
• Device Catalogue Number: 3501430
• Device Lot Number: 6785364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 09/19/2019; 09/25/2019; 10/31/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/11/2019; 09/20/2019; 09/27/2019; 11/01/2019
• 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: 50 YR