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Model Number 0416006
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
Explant date is estimated. Method of evaluation: manufacturing review: review of information as reported to lifecell, review of the device history records associated with lot s11232. Pathological examination: the explanted device was returned to lifecell for evaluation. Pathological gross analysis described a 10 x 7 x. 4cm shaggy, light blue deflated sac with a 2cm full-thickness laceration present in one focus. Cut surface shows a wrinkled light blue, shiny interior with a. 4cm fibrous wall. Microscopic diagnosis revealed a dense layer of fibrous tissue with autolytic changes. Few nonspecific inflammatory cells present, scattered among compressed breast ducts and lobules at the edges of the tissue. Vvg special stain for elastin shows no significant evidence of elastin fibers, consistent with incorporated strattice. Fungal and bacterial stains were negative for organisms. Results of evaluation: no failure detected. Qa investigation into lot s11232 resulted in no remarkable findings including no similar complaints reported against the lot and no deviations or nonconformances revealed during processing. As of (b)(6) 2017, of the (b)(4) devices released to finished goods for lot s11232, (b)(4)devices have been distributed. Lot s11232 was terminally sterilized and met all qc release criteria. Evaluation conclusion: no failure detected, device operated within specification. This event is being reported due to the surgical intervention to explant the strattice device unilaterally and the lack of clinical information including onset date and the patient's history since implantation in 2014. Pathological examination shows through vvg special stain for elastin that the tissue was consistent with incorporated strattice; thus the device performed as expected. Based on the results of the device evaluation and the qa investigation into lot s11232, the event is considered unrelated to the device and likely related to the patient's condition, including their history of recurrent capsular contracture prior to the implantation of strattice. No further actions are required as a nonconformance was not confirmed. Lifecell has made multiple attempts for additional information. If it is received, a follow up report will be submitted.
Event Description
It was reported that this is a female patient with a past surgical history of bilateral augmentation mammoplasty in 2004 with saline implants who presented with bilateral capsular contracture in 2012. At that time, the implants were exchanged to a similar sized gel implant (595cc) with open capsulectomy. Later, the patient elected to exchange the implants to a smaller size along with vertical mastopexy. Since then, the patient was doing well, however developed relatively minor capsular contracture (right greater than left). Although the cap con was relatively mild to moderate in degree, the patient had undergone multiple procedures. After the procedures, she continues to present with capsular contracture and was reported to have limited options. On (b)(6) 2014, ((b)(6) years old at this time) the patient underwent elective surgery to correct the cap con with strattice devices bilaterally (lots s11232-166, s11232-163). As per the operative report, the patient understood the risks, including but not limited to the recurrence of cap con. It was subsequently reported that the patient developed recurrent cap con following the surgery with strattice along with window shading of the muscle (onset date not reported). The patient was returned to surgery where strattice and capsule were explanted unilaterally (specific side and lot number not identified) by another surgeon and replaced with an alloderm graft. The explanted specimen was returned to lifecell for evaluation.
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Manufacturer (Section D)
one millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
one millennium way
branchburg, NJ 08876
MDR Report Key6786279
MDR Text Key82476652
Report Number1000306051-2017-00048
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2015
Device Model Number0416006
Device Catalogue NumberN/A
Device Lot NumberS11232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1