MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number 1010002

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

Patient Problems Adhesion(s) (1695); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 03/04/2016

Event Type  Injury  

Event Description

This is the same patient reported under mdr 1000306051-2023-00192 (abbvie complaint # (b)(4)).On 07/dec/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¿ surgery and was implanted with the initial strattice device on (b)(6) 2011.The patient underwent a "ventral incisional hernia repair¿ on (b)(6) 2013 by dr.(b)(6) at (b)(6) hospital.At that time, patient was implanted with another strattice device.The patient underwent a ¿diagnostic laparoscopy and combined laparoscopic and open repair of an incarcerated recurrent incisional hernia with mesh¿ on (b)(6) 2016.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, seroma, adhesions, bowel/intestinal obstruction or blockage, emotional injuries with and without treatment, inflammation, and intervention surgery¿.The form lists the conditions that were treated were ¿pain, recurrence, seroma, adhesions, bowel/intestinal obstruction or blockage, emotional injuries with and without treatment, inflammation, and intervention surgery¿ with approximate dates of treatment as (b)(6) 2016.The ppf form also indicates the patient was implanted with a non-abbvie device, "covidien/medtronic ¿ parietex composite (pco)¿ during the (b)(6) 2016 procedure and underwent a procedure on (b)(6) 2018 for ¿laparoscopic ligation of enterocutaneous fistula.¿.

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.A review of the device history record for strattice lot s11210 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 18432411
• MDR Text Key: 331862102
• Report Number: 1000306051-2024-00001
• 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,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 1010002
• Device Lot Number: S11210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2013
• 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 Age: 65 YR
• Patient Sex: Male