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

Model Number	3549212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
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.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.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a mentor cpx 4 breast tissue expander with suture tabs 350cc being used in a breast reconstruction primary was found to be leaking during the operation.No adverse event was experienced by the patient.A short procedural delay (10 minutes) was reported, but there were reportedly no adverse effects on the patient.The surgeon used a similar backup device (serial number (b)(4)) to complete the surgery.
Additional Manufacturer Narrative
Device evaluation summary: during the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, according to mentor procedure, and it revealed a tear on the posterior view, measuring approximately less than 0.1 cm.Microscopic examination of the edges of the tear revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.As part of our quality process, the manufacturing records of this lot-serial number 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 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: 10706162
• Report Number: 1645337-2020-13300
• Device Sequence Number: 17204930
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: 00081317006725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 08/22/2023
• Device Model Number: 3549212
• Device Catalogue Number: 3549212
• Device Lot Number: 9358232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1