MAUDE Adverse Event Report: MENTOR TEXAS EXP RECT REMOTE 550CC; EXPANDER, SKIN, INFLATABLE

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent an unspecified breast surgery with a mentor exp rect remote 550cc, tissue expander prosthesis experienced right-sided deflation post procedure.As a result, patient underwent replacement with a new expanders on (b)(6) 2022.
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).
Additional Manufacturer Narrative
Additional information received on august 22, 2022 indicated that the device was used on back of the patient.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated device evaluation completed on july 29 , 2022: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the exp rect remote 550cc tissue expander was found to have a tear on the union between shell and patch.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through mentor¿s quality system.During manufacturing, 100% of the devices were inspected for holes or tears.During the inspection, each device is inflated with air and submerged in 100% isopropyl alcohol (ipa).While submerged, a qualified operator will apply pressure on the device by gently squeezing and will observe for bubbles escaping the device that would indicate a leak.For the lot number reported in this complaint, no device was identified and rejected for leaks.In conclusion, with consideration to process controls and manufacturing records reviewed, the tear reported could not be confirmed as a manufacturing defect.Manufacturer¿s reference number: (b)(4).
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.Additional information received with the device indicated that the left side was deflated and date of explantation was on (b)(6) 2022., patient replaced with cat#: 3504310m, lot#: 7711996.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on july 08 , 2022: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the exp rect remote 550cc breast implant was found to have a tear on the union between shell and patch.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through mentor¿s quality system.During manufacturing, 100% of the devices were inspected for holes or tears.During the inspection, each device is inflated with air and submerged in 100% isopropyl alcohol (ipa).While submerged, a qualified operator will apply pressure on the device by gently squeezing and will observe for bubbles escaping the device that would indicate a leak.For the lot number reported in this complaint, no device was identified and rejected for leaks.In conclusion, with consideration to process controls and manufacturing records reviewed, the tear reported could not be confirmed as a manufacturing defect.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: EXP RECT REMOTE 550CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 13978453
• Report Number: 1645337-2022-03648
• Device Sequence Number: 5412900
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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

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: 04/16/2024
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 9430302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 07/08/2022; 07/29/2022; 08/04/2022; 08/22/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/11/2022; 08/02/2022; 08/05/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female