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

Catalog Number	3548007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2018
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 device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: gel mentor memorygel breast implant 800cc, catalog number 3548007, lot number 164430.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old female patient underwent a breast augmentation revision with a gel mentor memorygel breast implant 800cc and experienced bilateral rupture on the left and right breast implants.As a result, the patient will undergo explantation on (b)(6) 2018.This medwatch report is for the left breast implant.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the device history record (dhr) of lot number 165768 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
On 3/18/2019, 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
On (b)(6) 2019, it was reported to mentor that the date of explantation was actually (b)(6) 2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 4/29/19, device evaluation and investigation findings: upon receipt the device contained cloudy gel.Red material was observed within the device, yellow material and gel were observed on the shell surface.During initial examination a rupture within siltex cracking and a parallel lines of shell wear were observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.The rupture measuring approximately 1.8 cm.No other anomalies were observed.Rupture complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rupture within shell wear and siltex cracking were found in the device.The parallel lines of shell wear suggesting in-vivo folding or creasing of the device.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds (i.E., severe ¿v¿ or tight folds) in the htv ( high temperature vulcanization) shell of siltex breast implants.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.The manufacturing record evaluation (mre) of lot number 165768 was reviewed and no anomalies were found related to this complaint.In addition, the mre review verifies that the devices were manufactured in accordance with documented specification and procedures.At this point is not possible to determine the origin of the red and yellow materials found in the device.Because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: 7426929
• Report Number: 1645337-2018-01955
• Device Sequence Number: 16179194
• Product Code: FTR
• UDI-Device Identifier: 00081317000778
• UDI-Public: 00081317000778
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/16/2018

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: 11/30/2002
• Device Catalogue Number: 3548007
• Device Lot Number: 165768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 02/04/2019; 03/18/2019; 04/29/2019
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 04/30/2018; 02/04/2019; 03/18/2019; 04/30/2019
• 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: 58 YR