MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/03/2019
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 of tissue expander.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an unknown procedure with three mentor tissue expander 550cc devices that all deflated after implantation.These expanders became detached from the back twice.The first expander was placed in the upper left of the patient¿s abdomen, second expander in the lower left of the patient¿s abdomen, and the third expander in the mid right of the patient¿s abdomen.As a result, the patient had all three devices explanted on (b)(6) 2019.There were no replacements for the explanted devices.This medwatch report is for the device placed in the upper left of the patient¿s abdomen.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor received additional information about the event.The date of event is (b)(6) 2019.The patient was 69 years old at the time of event.On (b)(6) 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 07/01/2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information provided, the expander became detached from the back twice in 3 of these tissue expanders.During evaluation of the sample it was noticed to be intact.Leak testing was performed and a rupture was detected in the union between shell and patch at the posterior aspect.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Deflation is a known complication associated with mentor mammary prostheses.Possible causes of deflation of saline-filled implants include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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 july 6, 2020, the product investigation was updated.Device investigation summary: during the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed and it revealed a tear at the juncture of the shell and patch.Microscopic examination was performed and the cause of the deflation could not be identified.As part of our quality process, the manufacturing records of lot 7587593 were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8565974
• Report Number: 1645337-2019-10783
• Device Sequence Number: 11279067
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/08/2019

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: 08/08/2022
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 7587593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 07/01/2019; 07/06/2020
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/06/2019; 07/02/2019; 07/08/2020
• 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: 69 YR