MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR SMALL, PERFORATED; MESH, SURGICAL

Catalog Number	CS1097P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069); Skin Inflammation/ Irritation (4545)
Date of Event	04/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 04/21/2025, pmqa became aware of a clinical study in the usa reporting right breast erythema, swelling and pain.Site name: (b)(6) system.Relationship to study device (artia): not related.Relationship to study device procedure (artia implantation): not related.Patient received levaquin and toradol as prophylactic treatment.Patient has "anxiety and was concerned that the swelling in breast has increased since follow up the day prior." patient "went to the er the following day with concerns of worsening conditions.Er gave [them] medication to help with discomfort until next follow up, but no new symptoms were noted." this record represents 2 out of 2 artia pieces (related complaint number: (b)(6).Artia was removed."artia had not adhered to patient at all and seroma was heavily infected.Pi made the decision to remove device entirely.Sae and procedure documented.She has antibiotics now." "patient had erythema and drainage which tested positive for klebsiella.Conditions worsened from previous ae." relationship to artia is listed as 'possible.' organisms identified: klebsiella aerogenes and finegoldia magna on (b)(6) 2025."initially was breast irrigation with debridement which became a full device removal.After the pi did a breast exam and noticed the redness worsening and the cultures came back with kliebsella.After opening breast pocket and seeing no adherence and it floating in pus.Device completely removed and sent to pathology.Waiting on report currently.Patient is discharged and taking antibiotics now.".
Additional Manufacturer Narrative
This event is being reported as serious injury due to the reported infection with surgical intervention.A review of the device history record for artia lot: up200128 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the artia and this event could not be determined.If additional information is made available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Previous emdr submission noted event of e1720 skin inflammation/ irritation is a serious injury.Upon further review, this event is determined that it is not considered a serious injury.
Event or Problem Description
Healthcare professional reported a clinical patient experienced reporting right breast with erythema, swelling and pain that is heavily infected with seroma and drainage after implanting artia.The device has been explanted and patient is placed on antibiotics.After opening breast pocket, there no adherence and it floating in pus.Device completely removed and sent to pathology.Cultured noted positive for klebsiella aerogenes and finegoldia magna.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.6.
Event or Problem Description
Healthcare professional provided updated pathology report findings.""soft tissue, right breast artia acellular dermal matrix, excision: fibrous tissue with focal acute inflammation and focal early calcifications.No malignancy identified.".

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR SMALL, PERFORATED
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: terry ingram ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 22054597
• Report Number: 1000306051-2025-00057
• Device Sequence Number: 19876604
• Product Code: FTM
• UDI-Device Identifier: 00818410014476
• UDI-Public: (01)00818410014476(10)UP200128(11)230706(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2026

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: 05/31/2025
• Device Catalogue Number: CS1097P
• Device Lot Number: UP200128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 02/02/2026
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/20/2025; 02/18/2026
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American