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

Catalog Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
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 reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified procedure with an artoura breast tissue expander 500cc and experienced deflation (side unknown).As a result, the patient underwent removal on (b)(6) 2019.
Additional Manufacturer Narrative
On 4/6/2019, the mentor failure analysis lab received the device for evaluation.Device evaluation summary: upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.Upon visual examination it was found a rupture on a suture tab of the tissue expander.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.There is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8453257
• Report Number: 1645337-2019-09695
• Device Sequence Number: 3026526
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• 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
• Report Date (Section B): 03/05/2019

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: 09/03/2022
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7615734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/06/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention