MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	3507001BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); No Code Available (3191)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(b)(4).The product has not been returned.
Event or Problem Description
It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016.Date of explant is scheduled for (b)(6) 2017.Multiple attempts have been made to obtain clarification on this event.However, no further information has been made available.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
Additional Manufacturer Narrative
On 1/2/2018, mentor became aware that a second device was involved.As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it.Concomitant products: mentor memorygel smooth round moderate plus profile 700cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 1/2/2018, mentor became aware that a second device was involved.As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it.Concomitant products: mentor memorygel smooth round moderate plus profile 700 cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741.(b)(4).
Additional Manufacturer Narrative
On 3/29/2018, the device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device weighed 730.6 grams.The gel contained in the device appeared clear.No foreign material was observed within the device.Gel was observed on the shell surface.The product evaluation team (pe) discovered a rent measuring 18cm located on the anterior aspect, extending to the posterior aspect, produced during the decontamination process.No other anomalies were discovered.A root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred.Allergic response is a state of hypersensitivity induced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent or continued exposures.Materials used in the manufacture of silicone saline breast implants are considered biocompatible, however, anecdotal reports of allergic response are reported in the literature.Due to the multiple exposures of the patient to drugs, chemicals and materials in the intra-operative and postoperative phase, it is often difficult to determine the specific antigen causing an allergic response.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6795847
• Report Number: 1645337-2017-00054
• Device Sequence Number: 14616867
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2019
• Device Catalogue Number: 3507001BC
• Device Lot Number: 6855894-063
• Other Device ID Number: 3507001BC
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 07/17/2017; 07/17/2017; 07/17/2017; 09/10/2018
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 12/29/2017; 02/02/2018; 02/01/2018; 04/23/2018; 09/10/2018
• 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: Other; Required Intervention
• Patient Age: 42 YR