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

Catalog Number 2025002

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

Patient Problems Adhesion(s) (1695); Hernia (2240); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 01/28/2015

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported 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 Description

Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2014 and a 2nd strattice firm on (b)(6) 2015.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.This is the same event and the same patient reported under patient identifier (b)(6) (emdr-16127).This emdr is being submitted for the suspect product, first strattice firm.

Manufacturer Narrative

A review of the device history record for strattice lot s11228 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.

Event Description

This is follow up#1 to report on (b)(6) 2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event.This record is for the device implanted (b)(6) 2014.As per the ppf form, the patient underwent a ¿ventral hernia¿ surgery and was implanted with strattice device on (b)(6) 2014.The patient underwent an ¿exploratory laparotomy, lysis of adhesions, ileostomy takedown and redo ventral hernia repair with strattice mesh¿ on (b)(6) 2015.The patient was implanted with another strattice device on that date.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain and suffering, physical injury, loss of enjoyment of life, scarring, disfigurement, embarrassment, and economic and losses as a result of [their] strattice implant.¿ patient ¿suffered from wound infections and used a wound vac.¿ patient ¿wore an uncomfortable abdominal binder.¿ patient ¿had lifting restrictions and had to adjust [their] physical activities.¿ ¿it takes [the patient] longer to complete personal tasks.¿ patient ¿has difficulty taking long walks or walking up and down stairs.¿ patient ¿is dependent on others to help with the daily tasks he has difficulty completing himself.¿ the form lists the conditions that were treated were ¿ischemic colon with perforation, cholecystitis and infected marlex mesh with peritonitis, exploratory laparotomy, removal of infected mesh, subtotal colectomy with ileostomy, cholecystectomy, redo ventral hernia repair with strattice mesh¿ with approximate dates of treatment between (b)(6) 2014 and (b)(6).Patient was also treated for ¿bleeding from dermis around ostomy suction¿ on or about (b)(6) 2014.Patient received treatment for ¿open wound treated with a wound vac; ileostomy in place for ischemic colon¿ on or about (b)(6) 2014.Patient also underwent ¿open wound treated with wound vac and ileostomy in place for ischemic colon with perforation, granulation tissue excised, exploratory laparotomy, lysis of adhesions, ileostomy takedown, redo ventral hernia repair with strattice mesh, wound vac¿ with approximate dates of treatment between (b)(6) 2015 and (b)(6) 2015.Patient received treatment for ¿excessive drainage from incision site following ileostomy takedown¿ on or about (b)(6) 2015.Patient then underwent ¿wound vac removed, started on wet to dry dressing changes with dakins solution twice daily¿ on or about (b)(6) 2015.Patient had ¿wound check/maintenance; changed dressing¿ from 2014 to 2015.Patient received treatment for ¿chronic open abdominal wound, dehiscence with granulation tissue, sirs (systemic inflammatory response syndrome)¿ between (b)(6) 2016 and (b)(6) 2016.Patient had ¿ct abdomen & pelvis, large ventral hernia/diastases, open abdominal wall wound¿ on or about (b)(6) 2016.Patient received treatment for ¿abdominal wall pain - tender in right mid to lower abdomen, ct - possible adherence of bowel loops to the anterior abdominal wall¿ on or about (b)(6) 2016.The ppf form also indicates the patient was implanted with a non-abbvie device, ¿ventralight st¿ on (b)(6) 2014.The form indicates that this device was revised on (b)(6) 2014 due to ¿exploratory laparotomy, removal of infected mesh, subtotal colectomy with ileostomy, cholecystectomy, ventral hernia repair with strattice mesh.¿ as reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2014 and a 2nd strattice firm on (b)(6) 2015.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.This is the same event and the same patient reported under patient identifier cn-057782 (emdr-16127).This emdr is being submitted for the suspect product, first strattice firm.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18461394
• MDR Text Key: 332253266
• Report Number: 1000306051-2024-00011
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 2025002
• Device Lot Number: S11228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male