MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341354
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Local Reaction (2035); No Code Available (3191)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
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.Reason for device explant and/or reoperation: rupture of right breast prosthesis.Concomitant products: mentor memoryshape breast implant 610cc gel breast prosthesis, catalog #3341354, serial (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation procedure with a mentor memoryshape breast implant 610cc gel breast prosthesis that ruptured after implantation.The patient first noticed leakage from her right breast prosthesis and called a physician for advice.The physician confirmed the leak and prescribed antibiotics.In addition, the patient developed edema in her right breast.As a result, the patient underwent explantation and replacement with a mentor memoryshape breast implant 610cc gel breast prosthesis on (b)(6) 2019.Rupture of the right breast prosthesis was confirmed by the physician during explantation surgery.
Additional Manufacturer Narrative
On 07/01/2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported the patient experienced a rupture and local reaction in the breast implant.During analysis of the sample a tear was noted in the anterior view, measuring approximately 11.9 cm.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 11/01/2019, mentor completed a second investigation on the suspect medical device.An additional test was performed on the device.Device evaluation summary: according to the information reported, the patient experienced a rupture and local reaction in the breast implant.During analysis of the sample, a tear was noted in the anterior view, measuring approximately 11.9 cm.Microscopic examination was performed and no evidence of instrument damage was observed.No other anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Mechanical testing was conducted on complaint samples including tension set to evaluate the residual elongation, joint strength to examine the ability of the shell/patch bond to withstand stress while the shell material adjacent to the bond is elongated, and tensile/elongation to measure the inherent material behavior.All testing results met or exceeded the international standards.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma,excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8658848
• Report Number: 1645337-2019-12975
• Device Sequence Number: 2446027
• Product Code: FTR
• UDI-Device Identifier: 00081317024255
• UDI-Public: 00081317024255
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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: 06/19/2023
• Device Catalogue Number: 3341354
• Device Lot Number: 7581981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 11/01/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/02/2019; 11/05/2019
• 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: 52 YR