MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3548312
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2019
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent primary breast surgery with 350cc saline mentor cpx 4 breast tissue expanders and experienced deflation on the left side intra-operational.As a result, the device was exchanged with a similar product.
Additional Manufacturer Narrative
Additional information: on 1/13/2020, 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 02/20/2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, intraoperative deflation of a tissue expander was reported.During the visual evaluation of the device, it was observed with no apparent damage.Blue liquid was noted within the device.Leak testing was performed, and it revealed a tear measuring less than 0.1 cm on the patch.Microscopic examination was performed and the cause of the rupture could not be identified.Multiple attempts have been made to obtain clarification regarding the blue liquid found inside the device; however, it has not been made available.As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection since this could compromise the product integrity.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.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).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9516918
• Report Number: 1645337-2019-26100
• Device Sequence Number: 13943113
• Product Code: LCJ
• UDI-Device Identifier: 00081317006596
• UDI-Public: 00081317006596
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: 3548312
• Device Catalogue Number: 3548312
• Device Lot Number: 7713345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 02/20/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 01/27/2020; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1