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

Model Number	3549314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	11/24/2020
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: soft-tissue necrosis, deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent a primary breast reconstruction with 550cc mentor cpx 4 breast tissue expander with suture tabs experienced left-sided expander deflation and soft-tissue necrosis postoperatively.The tissue expander had undergone six subsequent fills when deflation was confirmed by the surgeon.Furthermore, the patient also suffered partial skin flap necrosis four days post-op and required debridement.As a result, the patient underwent explantation and replacement with unspecified device on (b)(6) 2021.
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.Per the documentation received with the device, device explantation date was updated to 21-apr-2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 31-aug-2021, the investigation on the suspected medical device was completed.Investigation summary: mentor then conducted a visual inspection, leak test, and microscopic examination of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed according to mentor procedure, and it was identified three (3) tears (a, b and c) on the anterior aspect, measuring each tear approximately 0.1 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tears.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, microscopic examination of the returned product indicates that the tissue expander could have being damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.Necrosis may prevent or delay wound healing and require surgical correction, which may result in additional scarring and/or loss of tissue.Implant removal may also be necessary.Necrosis is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 11829041
• Report Number: 1645337-2021-05404
• Device Sequence Number: 19780617
• Product Code: LCJ
• UDI-Device Identifier: 00081317006800
• UDI-Public: 00081317006800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2021

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: 03/31/2024
• Device Model Number: 3549314
• Device Catalogue Number: 3549314
• Device Lot Number: 9443921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 08/31/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/16/2021; 09/02/2021
• 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: 36 YR