MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number	1620002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069); Hernia (2240)
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6)2020.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
Additional Manufacturer Narrative
This legal event is being reported out of an abundance of caution as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional and/or corrected data: h6 a review of the device history record for strattice lot sp200136 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.A relationship between the strattice and this event could not be conclusively determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up#1 to report on 12/sept /2023, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the 63-year-old male patient underwent an ¿incarcerared recurrent ventral hernia¿ repair on (b)(6) 2020 and was implanted with strattice mesh device lot sp200136-022.The patient then underwent an ¿image guided aspiration of anterior abdominal wall seromas¿ on (b)(6) 2020.The ppf form also indicates the patient was not implanted with any other devices.Additional information from the medical records states that the patient has a past medical history of significant coronary artery disease status post triple bypass, hypertension, dyslipidemia, stroke, and tia.During the initial implant surgery on (b)(6) 2020, the wound class was clean-contaminated.The abdomen wound was irrigated with copious amounts of saline solution, and they closed the fascia, sewing in the strattice mesh in an interrupted fashion.A jp drain was placed through the skin above the fascia to avoid any seromas or abscess formation.The patient presented to the er a few times since the hernia repair.On (b)(6) 2020, the patient presented with lower abdominal pain, dysuria and constipation and the ct scan revealed a seroma.There was concern for it being infected so the patient was started on antibiotics and admitted to the medical floor.A total of 400 ml of serosanguinious fluid was aspirated.The superficial anterior abdominal seroma in the lower abdomen drained 300 mls of fluid and the deeper anterior abdominal seroma in the lower abdomen just superficial to the hernia mesh was accessed and 100 mls of fluid was aspirated.Both sets of fluid were sent for culture.Culture results were not provided.It was noted the patient refused drainage catheter since he states he was unlikely to follow up.The patient was informed to wear abdominal binder to minimize risk of seroma recurrence.The patient claims the implantation of the strattice mesh has caused ¿seroma, abscess, pain and suffering.¿ no other information was provided.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2020.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 17217811
• Report Number: 1000306051-2023-00147
• Device Sequence Number: 6185824
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: 06/30/2021
• Device Catalogue Number: 1620002
• Device Lot Number: SP200136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male