MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number	1016002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
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) 2018.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 as serious injury due to the reported recurrence with surgical intervention.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.
Additional Manufacturer Narrative
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
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 hernia¿ surgery and was implanted with strattice device catalog 1016002 on (b)(6) 2018.The patient underwent a "mesh excision, small bowel resection¿ on (b)(6) 2021.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿adhesions, inflammation, bowel complications and obstruction, intense chronic pain, mental anguish attributed to pain, and mental and emotional distress attributed to bowel complications¿.The form lists the conditions that were treated were ¿adhesions, inflammation, bowel obstruction and complications, and chronic pain¿ with approximate dates of treatment between (b)(6) 2021.The form also lists additional treatment for ¿abdominal pain¿ with approximate dates of treatment between (b)(6) 2021 and for ¿adhesions, chronic pain, erythematous small bowel¿ with approximate dates of treatment between (b)(6) 2022.The ppf form also indicates the patient was implanted with non-abbvie devices, "parietex, parietex, symbotex¿ on (b)(6) 2016.The symbotex was revised on (b)(6) 2017 for ¿hernia recurrence and exposed mesh.¿ the parietex devices were revised on (b)(6) 2019 for ¿bilateral inguinodynia, entrapped cord structures and fibrosis.¿ previous medwatch submission noted re-herniation.Upon further information, abbvie has determined that the event of re-herniation did not occur.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, 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: 17773536
• Report Number: 1000306051-2023-00218
• Device Sequence Number: 15391043
• Product Code: FTM
• UDI-Device Identifier: 00818410010119
• UDI-Public: 00818410010119
• 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: 2018
• Device Explanted Year: 2021
• 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): 12/28/2023

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 Catalogue Number: 1016002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male