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

Model Number	3504305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Code Available (3191); Insufficient Information (4580)
Date of Event	12/30/2019
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast reconstruction primary with mentor tissue expander exp rnd remote 400cc, breast implants which the left side deflated after implantation the deflation happened after 500cc water injection.As a result patient had the device removed on (b)(6) 2020.
Additional Manufacturer Narrative
On july 7th, 2020 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary completed on august 4 2020: during the visual evaluation of the tissue expander, it was noted that tubing and injection reservoir was separated of the tissue expander.In addition, two (2) tears (a and b) were observed on the anterior aspect of the expander, measuring approximately both tears 0.5 cm.During the visual evaluation of the injection reservoir, no apparent damage was observed.Leak testing was performed to the microinjection reservoir in accordance with mentor procedures, and no leak sites were detected.Microscopic examination in the edges of the ruptures revealed parallel striations in the tubing and both tears 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.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing breast implants are not considered lifetime devices and deflation/rupture is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Upon review of this event, mentor has become aware that the type of procedure was incorrect in the previous submissions.This device was being used in a reconstructive skin surgery on the patient¿s right arm.Manufacturer's reference number: (b)(4) procedure type previously reported has been updated in section h10.
Additional Manufacturer Narrative
Correction: an incorrect patient code (3191 ¿ no code available) was used for this event.The correct code has been added.Manufacturer¿s reference number: (b)(4).H6 health effect - clinical code: e2401 "insufficient information".

• 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: 10280410
• Report Number: 1645337-2020-08718
• Device Sequence Number: 19080584
• Product Code: LCJ
• UDI-Device Identifier: 00081317002413
• UDI-Public: 00081317002413
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/22/2020

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: 06/13/2023
• Device Model Number: 3504305M
• Device Catalogue Number: 3504305M
• Device Lot Number: 7737416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 08/04/2020; 07/15/2021; 08/02/2021
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/21/2020; 08/06/2020; 07/15/2021; 08/03/2021
• 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: 23 YR