MAUDE Adverse Event Report: LIFECELL BPS STRATTICE 8 CM X 8 CM - PLIABLE; MESH, SURGICAL

Catalog Number 0808006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Foreign Body Reaction (1868); Discharge (2225)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

In response to fda report number mw5091523.Internal investigation into lot number sp200022 has been initiated.A follow up medwatch will be sent once the investigation is completed.(b)(4).

Event Description

It was reported that a patient underwent an implant exchange surgery and was implanted with allergan breast implants and strattice on (b)(6) 2018.Almost one year later, patient presented with a spontaneous exposed left breast implant.They ended up in the er, labs were drawn and a culture was taken of the abscess fluid on the right breast.They were put on antibiotics and within 24 hours, their incision started to open up.Their implant and unincorporated strattice was exposed.A surgeon identified the strattice and removed the exposed strips, and patient's right side implant was removed about a week later.Two days after the removal of the implant, a left abscess appeared, and the implant was removed.Patient had drains placed and immediately started to discharge a thick, green mucous.All cultures from drainage and tissue and all blood tests showed no bacteria, no fungus, no inflammatory markers.Their incisions started to open again and another hole formed on their right breast and dealt with extreme discharge.Breast implants and any leftover adm were removed.After surgery, the green discharged stopped.The right breast healed, and the left breast had cellulitis.Patient was taken to the hospital where they received iv antibiotics, blood draw, culture of discharge from cellulitis and an ultrasound.Patient went to an infusion center every 12 hours.Patient left side incision started to open up again and had to go to the complex care at the hospital for specialized wound care.Patient still has an open wound and does not feel like they are healing.Patient found out the capsule was not completed removed because their doctor said they needed it over their lungs.Patient fears the strattice is still left in their body and causing harm to them as well as the deformity of their breasts.All of their doctors indicated it was the adm causing the issue.All tissue cultures, blood tests and serum cultures came back normal.Patient had no infection, no fungus, no cancer.Nurse initially stated that the strattice had no relation to this event and then followed up by stating said that the patient was symptomatic with the strattice and implants.The symptoms continued after strattice and implants were removed.There was no relation to the strattice or implants; however, they were uncertain what the cause was, since the implants and strattice had been implanted one year prior to symptoms presenting.Strattice and implant were explanted on (b)(6) 2019.The strattice is not available for return.The affected lot number is sp200022.

Manufacturer Narrative

Lot: sp200022 was stored and shipped under established conditions with no deviations or nonconformances related to storage or shipping revealed.As of 28/jan/2020, there was one unrelated complaint which was associated with an infection not caused by the strattice.Review of the processing history records for lot: sp200022 is as follows: lot processing start date: 7/30/2018; sterilization date: 08/09/2018; expiration date: 2020-07-31; sterilization e-beam doses were within process parameters.Dose audit (b)(4) for the sterilization process was acceptable for the lot.Bacterial endotoxins limit test (bet) results: passed: 08/30/2018 pouch integrity inspection showed no significant bulges, holes, tears, wrinkles or physical defects.Pouch seals dwell time and temperatures were within process parameters.Seal integrity inspection showed that all seals were visually inspected and acceptable.The lot was aseptically processed, terminally sterilized, and met qc release criteria.There were no processing deviations and 2 unrelated nonconformances ((b)(4)) revealed during the investigation.Unrelated (b)(4), strattice, possible multiple pieces in a single pouch found in kitting, sp200022.Final patient and product impact is none.Unrelated (b)(4), equipment work request (ewr) out of service sign was mistakenly removed.Final patient/product impact is high and disposition is reject for lots affected.Sp200022-533 was not affected by this ncr.(b)(4).Qa investigation into lot: sp200022 resulted in no remarkable findings including (b)(4) devices distributed with no other complaints and no related processing deviations or nonconformances revealed.Lot: sp200022 was processed aseptically, terminally sterilized and met all qc release criteria.

Event Description

It was reported that a patient underwent an implant exchange surgery and was implanted with allergan breast implants and strattice on (b)(6) 2018.Almost one year later, patient presented with a spontaneous exposed left breast implant.They ended up in the er, labs were drawn and a culture was taken of the abscess fluid on the right breast.They were put on antibiotics and within 24 hours, their incision started to open up.Their implant and unincorporated strattice was exposed.A surgeon identified the strattice and removed the exposed strips, and patient's right side implant was removed about a week later.Two days after the removal of the implant, a left abscess appeared, and the implant was removed.Patient had drains placed and immediately started to discharge a thick, green mucous.All cultures from drainage and tissue and all blood tests showed no bacteria, no fungus, no inflammatory markers.Their incisions started to open again and another hole formed on their right breast and dealt with extreme discharge.Breast implants and any leftover adm were removed.After surgery, the green discharged stopped.The right breast healed, and the left breast had cellulitis.Patient was taken to the hospital where they received iv antibiotics, blood draw, culture of discharge from cellulitis and an ultrasound.Patient went to an infusion center every 12 hours.Patient left side incision started to open up again and had to go to the complex care at the hospital for specialized wound care.Patient still has an open wound and does not feel like they are healing.Patient found out the capsule was not completed removed because their doctor said they needed it over their lungs.Patient fears the strattice is still left in their body and causing harm to them as well as the deformity of their breasts.All of their doctors indicated it was the adm causing the issue.All tissue cultures, blood tests and serum cultures came back normal.Patient had no infection, no fungus, no cancer.Nurse initially stated that the strattice had no relation to this event and then followed up by stating said that the patient was symptomatic with the strattice and implants.The symptoms continued after strattice and implants were removed.There was no relation to the strattice or implants; however, they were uncertain what the cause was, since the implants and strattice had been implanted one year prior to symptoms presenting.Strattice and implant were explanted on (b)(6) 2019.The strattice is not available for return.The affected lot number is sp200022.

• Brand Name: BPS STRATTICE 8 CM X 8 CM - PLIABLE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 9602513
• MDR Text Key: 189481302
• Report Number: 1000306051-2019-00129
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010256
• UDI-Public: 00818410010256
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0808006
• Device Lot Number: SP200022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BREAST IMPLANTS
• Patient Outcome(s): Required Intervention