MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Type of Reportable Event	Serious Injury
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.
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.
Event or Problem Description
This is follow up#1 to report on 28/aug/2023, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent a ¿ventral incisional hernia repair with adherene, erosion of small bowel into previous mesh; exploratory laparotomy; mid small bowel resection and performance of side-by-side stapled anastomosis following a small bowel enterotomy; explantation of previous periumbilical mesh¿ and ¿repair of ventral incisional hernia¿ with strattice mesh device lot sp200147-104 on (b)(6) 2020.The ppf form also lists additional conditions treated as ¿evaluation of abdominal bulge with pain when touched; ct abd/pelvis - large ventral midline abdominal wall hernia containing loops of predominantly small bowel¿ in (b)(6) 2020.¿recurrent incisional hernia; recommended an open, retrorectus incisional hernia repair with synthetic mesh placed in a preperitoneal position; growth and pain at site; nausea¿ on (b)(6) 2021.¿suprapubic pain and difficulty with urination; continuation of non-surgical abdomen with reducible hernia¿ on (b)(6) 2021.The patient then underwent an ¿open repair of recurrent ventral hernia; implantation of mesh (bard soft in a retrorectus position); lysis of adhesions (complex), requiring approximately 45 minutes; myofascial release, bilateral¿ on (b)(6) 2021.¿pain with movement; possible bulge in operative region¿ on (b)(6) 2021.The ppf form also indicates the patient was implanted with non-abbvie devices, "bard ventralex st mesh¿ on (b)(6) 2016 and ¿bard soft¿ on (b)(6) 2021.No ¿revision¿ or ¿removal¿ was reported based on the dates for the non-abbvie devices.The patient claims the implantation of the strattice mesh resulted in ¿pain and suffering, physical injury, loss of enjoyment of life, and economic and non-economic losses because of his strattice implant.He suffers from abdominal pain.Mr.(b)(6) has lifting restrictions causing him to adjust his physical activities.He has difficulty performing outdoor activities such as hunting, hiking, long walks, home maintenance and sports with his son.He has difficulty with household chores such as mopping, sweeping, and vacuuming.Mr.Reece¿s abdominal area is disfigured and scarred, causing him embarrassment.He is fearful he will suffer another hernia in the future¿.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.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp200147 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 strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, 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: 17199090
• Report Number: 1000306051-2023-00142
• Device Sequence Number: 17502992
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• 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): 09/13/2023

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: 07/31/2021
• Device Catalogue Number: 2025002
• Device Lot Number: SP200147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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 Sex: Male