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

Model Number	3549314
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
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 for the finished device number 7596933, and no non-conformances related to the reported complaint were identified.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female underwent primary breast reconstruction with a 550cc mentor cpx 4 breast tissue expander with suture tabs during a procedure and could not fill the device during a procedure.This issue was not associated with an adverse event to the patient.The physician utilized another 550cc mentor cpx 4 breast tissue expander with suture tabs to complete the procedure.
Additional Manufacturer Narrative
On june 15, 2020 mentor became aware that it erroneously placed the wrong statement in the device evaluation summary submitted on that same date.The incorrect statement was: the investigation of the returned photograph was completed by the failure analysis lab on june 12, 2020.The correct statement was: the investigation of the returned device was completed by the failure analysis lab on june 12, 2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on (b)(6) 2020.Additionally, the cause of the product issue was a hole in the tissue expander, creating deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned photograph was completed by the failure analysis lab on (b)(6) 2020.Device evaluation summary: during visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed according to mentor procedures, and a tear was observed at the patch on the posterior view.Microscopic examination of the tear edges revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.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 CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8506907
• Report Number: 1645337-2019-10201
• Device Sequence Number: 1465458
• Product Code: LCJ
• UDI-Device Identifier: 00081317006800
• UDI-Public: 00081317006800
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2019

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: 06/17/2022
• Device Model Number: 3549314
• Device Catalogue Number: 3549314
• Device Lot Number: 7596933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/19/2020; 06/15/2020; 06/15/2020
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/10/2020; 06/15/2020; 06/15/2020
• Patient Sequence Number: 1
• Patient Age: 32 YR