MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 10160001EU

Device Problem Degraded (1153)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Edema (1820); Unspecified Infection (1930); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 03/29/2014

Event Type  Injury  

Event Description

Subject (b)(6) female enrolled in (b)(6), as part of the lifecell sponsored clinical study- (b)(4).The (b)(6) year-old female subject underwent a bilateral mastectomy and direct to implant reconstruction with 10 x 16 cm lifecell devices and allergan implants on (b)(6) 2014.On (b)(6) 2014 (pod 1day), the subject started developing pus secretion at a pin needle wide opening (left breast) and a generalized edema, wound infection with dehiscence, and portions of the device partially visible in the open wound (right breast).On (b)(6) 2014 (pod 1m), the subject presented with a severe seroma on the right side which resulted in dehiscence despite aspiration.The subject was hospitalized for intravenous antibiotic therapy.Purulent drainage was noted with just a pinhead-sized opening in the wound in the imf area (left breast) and wound infection with dehiscence and exposed sections of the device were noted (right breast).On (b)(6) 2014, the subject underwent removal of the right breast implant and remaining device sections, all visible residual suture material, and sponge packing of wound bed and application of npwt (negative pressure wound therapy) was initiated.The device was described as almost completely dissolved (looking like gelatin) and was discarded.No pictures were taken.Bacterial cultures were taken (right breast).The left implant and device was left in place at that time and existing antibiotic therapy was continued.On (b)(6) 2014, the subject had a second surgery due to chronic seroma resulting in a fairly large wound dehiscence and suspected infection (left breast).The device was described as slightly digested and no longer adherent.The implant and the device were removed and a vacuum sponge was inserted.The device was discarded.No signs of infection were noted on the left side.Pictures were taken of this surgery.Bacterial cultures were taken and application of npwt was initiated (left breast).On (b)(6) 2014, the patient had a subsequent surgery for change of vacuum sponges.The subject still had npwt in place on both sides.Soft tissues of the breasts appeared healthy on examination.Fluid collected via npwt appeared clear.Microbiology of (intra op) npwt-changes showed no growth.(left and right breast) patient has generalized fluid retention (+4 kg) with tissue edema both flanks, thighs, lower legs of unclear origin.Serum parameters inclusively gfr normal, soft tissue envelope noco normalized.Nephrology consult was normal, diuresis ovn 4 days initiated.A procedure to exchange the npwt to implants bilaterally was planned for (b)(6) 2014.The adverse event is ongoing.The investigator/physician assessed the event relationship as possibly related to the study device and probably related to the procedure.

Manufacturer Narrative

Clarification: the two devices were explanted on different dates.(b)(6) explanted from the right breast on (b)(6) 2014; (b)(6) explanted from the left breast on (b)(6) 2014.Method of evaluation: review of information reported to lifecell; review of the device history record for lot s11250; review of the lifecell complaint system.Results: investigation into lot s11250 resulted in no remarkable findings, including acceptable sterilization and no deviations or non conformances revealed during processing.A query of the complaint management system on (b)(6) 2014 revealed no other complaints reported against lot s11250.As of (b)(4) 2014, (b)(4) devices have been distributed from lot s11250, including (b)(4) devices reported as implanted.Lot s11250 met all qc release criteria.Conclusion: device not returned.Seroma is an anticipated postoperative complication associated with this type of surgical procedure.The wound dehiscence reported is an event associated with postoperative complications such as seroma.While infection was suspected in the left breast, no signs of infection were noted during the surgery on (b)(6) 2014.Cultures were taken on both the right and left breasts during explantation surgery and the results will be reported in a follow-up report.Internal investigation resulted in no remarkable findings, including 619 devices distributed with no other clinical complaints reported against lot s11250 and device history record review with acceptable device sterilization and no deviations or nonconformances revealed during processing.The reported wound infection and device extrusion through the open wound (right breast) and the seroma and wound dehiscence, in addition to the suspected infection, (left breast) was treated with surgical intervention and explantation of the lifecell devices.The explanted devices were discarded.No product or specimens were returned to lifecell for evaluation.Lot s11250 met all qc release criteria.Bacterial cultures were taken on both the right and left breasts during explantation surgery.The results have not yet been received.The culture results will be reported in a follow-up report along with an updated conclusion.The adverse event is ongoing.Explanted devices discarded by physician.

Manufacturer Narrative

Follow up narrative: method of evaluation: review of additional information reported to lifecell results of evaluation: the surgical report dated (b)(6) 2014 reported that all of the microbiological cultures have been negative to date and there are no signs of infection.Based on the investigator's statement, the fluid retention throughout the subject's body following routine steroid use in connection with the initial surgery ultimately resulted in development of the late seroma conclusion code: seroma is an anticipated postoperative complication associated with this type of surgical procedure.The wound dehiscence reported is an event associated with postoperative complications such as seroma.While infection was suspected in the left breast, all of the microbiological cultures have been negative to date, and there are no signs of infection.Internal investigation resulted in no remarkable findings, including (b)(4) devices distributed with no other clinical complaints reported against lot s11250 and device history record review with acceptable device sterilization and no deviations or nonconformances revealed during processing.The reported wound infection and device extrusion through the open wound (right breast) and the seroma and wound dehiscence, in addition to the suspected infection, (left breast) was treated with surgical intervention and explantation of the lifecell devices.The explanted devices were discarded.No product or specimens were returned to lifecell for evaluation.Lot s11250 met all qc release criteria.Based on the information reported, including the investigator's statement that the fluid retention throughout her body following routine steroid use in connection with the initial surgery ultimately resulted in development of the late seroma, the negative culture results and the internal investigation into the complaint related lot with no remarkable findings, lifecell concludes that the events are unlikely related to the devices.Explanted devices discarded by physician.

Event Description

This report is a follow up/final report to the original report emdr 1000306051-2014-00037 to update the event, culture results and conclusion.Additional information was translated and received on 05/29/2014.The surgical report dated (b)(6) 2014 reported that all of the microbiological cultures have been negative to date, and there are no signs of infection.The subject was found to have gained 4.5 kg since the surgery and generalized edema was found throughout the thoracic and abdominal regions and in the lower extremities.A nephrology consult did not reveal any signs of renal dysfunction.Blood and inflammation parameters are within normal range.According to the subject, the weight gain occurred since the initial surgery in (b)(6) of this year, but she never brought it to the physician's attention.The investigator now suspects that the subject may have experienced fluid retention throughout her body following routine steroid use in connection with the initial surgery, which ultimately resulted in development of a late seroma five weeks after that procedure.The subject was being treated with diuretics, and the subcutaneous edema in the flanks and lower extremities was resolving, as was the volume of fluid aspirated with the nwpt (negative wound pressure therapy) dressing.It was reported that the amount of fluid in both of the nwpt dressings dropped to an absolute minimum, and the subject's generalized body fluid had been completely flushed out, so the nwpt removal could be performed along with reinsertion of the final silicone implants.The subject was informed that there is an increased risk of capsular contracture since no acellular dermal matrix would be in place this time.The procedure was completed and the final implants (both left and right) were inserted without any acellular dermal matrix.One drain was inserted on each side and the wounds were closed.It was reported that the subject came through the procedure well.Additional information was translated and received on 06/24/2014.On (b)(6) 2014, the subject underwent a bilateral nwpt removal, jet lavage and implant insertion (both breasts).The peri- and postoperative course was uneventful and the drains were removed on the 6th postoperative day after wound drainage had ceased.The subject was discharged on (b)(6) 2014 in good health.Sae stop date: (b)(6) 2014; the subject/patient is reported as doing well without any further complications.(refer to original report for original event description).

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: stanley dube ; one millennium way; branchburg, NJ 08876 ; 9089471575
• MDR Report Key: 3830528
• MDR Text Key: 4501841
• Report Number: 1000306051-2014-00037
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: 10160001EU
• Device Catalogue Number: N/A
• Device Lot Number: S11250-678 & S11250-679
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALLERGAN BREAST IMPLANTS
• Patient Outcome(s): Other
• Patient Age: 47 YR