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

Model Number	3505305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Code Available (3191); Insufficient Information (4580)
Date of Event	10/23/2020
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.(b)(4).Reason for device explant and/or reoperation: deflation.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an abdominoplasty with a mentor tissue expander and experienced deflation post-operatively.As a result, the patient underwent removal and replacement with a similar device on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 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
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 located at a junction of the shell and patch.Microscopic examination was performed and the cause of the deflation could not be identified.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).
Additional Manufacturer Narrative
Upon additional review on jul 28 2021, it was decided to update h6.Health effect - clinical code to e2401 (insufficient information).At this time, no information has been received indicating any particular patient harms were experienced.Manufacturer¿s reference number: (b)(4).

• 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: 10870563
• Report Number: 1645337-2020-14847
• Device Sequence Number: 19915730
• Product Code: LCJ
• UDI-Device Identifier: 00081317002581
• UDI-Public: 00081317002581
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 10/27/2020

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: 04/29/2023
• Device Model Number: 3505305M
• Device Catalogue Number: 3505305M
• Device Lot Number: 7701964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/23/2020; 01/13/2021; 07/28/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/14/2020; 01/14/2021; 07/29/2021
• 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: 38 YR