MAUDE Adverse Event Report: BRANCHBURG STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL

Catalog Number	2030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, 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 on (b)(6) 2017.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
Clarification to h6: previous medwatch submission noted re-herniation.Upon further information, abbvie has determined that the event of re-herniation did not occur.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 or Problem Description
This is follow up#1 to report on 16/aug/2024, 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 hernia surgery and was implanted with a strattice device lot #spj00518-132 (not valid) and ref.#(b)(4) on (b)(6) 2017.On (b)(6) 2021, patient underwent exploratory laparotomy with extensive lysis of adhesions, radical excisional debridement of abdominal wall, including skin/scar/stsg/subq/myofascial tissue, incision and drainage of abdominal wall fluid collection, resection of infected mesh, and removal of intra-abdominal abscess/suture mater.The strattice was removed and patient was implanted with another strattice device lot #sp200287-058 on (b)(6) 2021.Patient later experiencing some issues with the mesh potentially curling up.The form lists the condition that was treated was: adhesions, infection, drainage, abscess between (b)(6) 2021.The ppf form also indicates that the patient was implanted with a non-abbvie device, gore-tex, lot #unknown in 2001 and bard soft mesh lot # huau1707 with bard soft mesh lot #huav0166 soft pro on (b)(6) 2016.The form indicates that the device was removed/revised on (b)(6) 2010 open ventral hernia repair; (b)(6) 2016 repair of multiple incarcerated ventral incisional hernia with explantation of old mesh x 2, debridement of abdominal wall, umbilectomy, open cholecystectomy, creation of right & left posterior rectus sheath myofascial advancement flaps, right & left transversus abdominis release myofascial advancement flaps, right & left epigastric perforator sparing skin flaps x 2 & right & left vascularized peritoneal flaps.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2017.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, 20 X 30, FIRM
• Common Device Name: 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: 19533468
• Report Number: 1000306051-2024-00173
• Device Sequence Number: 15379701
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: 00818410010393
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2030002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 67 YR
• Patient Sex: Female