MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE BPS; SURGICAL MESH

Model Number CON3006

Device Problem Material Rupture (1546)

Patient Problems Bacterial Infection (1735); Seroma (2069)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of information as reported, review of the device history records and complaint history records associated with lot sp100363.Results of evaluation: (b)(4).- review of the device history records revealed no deviations during the production of lot sp100363 that may be associated with the event.Lot irradiation doses were within process parameters.The lot was aseptically processed and met acceptance criteria for qc release, including mechanical testing results.As of 10/18/2016, no other complaints have been reported to lifecell against lot sp100363.As of 10/18/2016, of the (b)(4) devices released to finished goods for lot sp100363, (b)(4) devices were distributed.Evaluation conclusion: (b)(4).Conclusion: based on our internal investigation into lot sp100363 with no remarkable findings, including no other complaints against lot sp100363, the event is unlikely related to strattice bps.Lot sp100363 was aseptically processed and completed e beam sterilization within established parameters with no nonconformities or deviations related to this event.Patient factors, including history of multiple revision surgeries may have contributed to this event.Infections associated with a specific type of procedure via documented scientific literature (e.G.Mycobacterium or staphylococcus aureus associated with breast cancer or implant surgery) would demonstrate that the associated infection is a known risk factor for the surgical procedure.Device not returned for evaluation.

Event Description

It was reported to lifecell that a (b)(6) female patient underwent bilateral capsulectomy, mastopexy revision, and pocket reinforcement with strattice bps on (b)(6) 2016.Intraoperatively, the surgeon removed and replaced silicone implants where the left implant was found to be intact, but the right implant had ruptured and all material was removed.On (b)(6) 2016, the patient presented with a post operative prosthetic infection to the left breast.On (b)(6) 2016, the patient was returned to the operating room for removal of the silicone implant to the left breast.Cultures were swabbed from the breast pocket and revealed coagulase negative staphylococcus.The patient was treated with oral antibiotic therapy.On (b)(6) 2016, the seroma fluid from left breast was aspirated and cultured.No organisms were seen.On (b)(6) 2016, the patient was returned to the operating room for removal of strattice graft from the left breast.Currently, the patient is healthy and the infection has resolved.She is scheduled for surgery to replace the left breast implant and strattice graft on (b)(6) 2016.

• Brand Name: STRATTICE BPS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: paul arrendell ; one millennium way; branchburg, NJ 08876 ; 9089471110
• MDR Report Key: 6048136
• MDR Text Key: 58099856
• Report Number: 1000306051-2016-00067
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: CON3006
• Device Catalogue Number: N/A
• Device Lot Number: SP100363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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: SILICONE BREAST IMPLANTS
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR