MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, FIRM; MESH, SURGICAL

Catalog Number	0808002
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
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.
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice 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
Additional, changed, and/or corrected data: a.2, b.5, d.1, d.4, d.6b, g.2, h.6 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.
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice 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.On (b)(6) 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 ¿parastomal hernia¿ repair and was implanted with strattice device lot unknown on (b)(6) 2018.The patient underwent a "parastomal hernia repair and adhesiolysis¿ on (b)(6) 2018.The patient also underwent an ¿open recurrent parastomal hernia repair with acell graft placement and lysis of adhesions (1 hour)¿ on (b)(6) 2018.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, mesh migration, peristomal fullness and pain, adhesions, bowel/intestinal obstruction and blockage, and intervention and mesh removal surgery¿.The form lists the conditions that were treated were ¿pain, recurrence, mesh migration, peristomal fullness and pain, adhesions, bowel/intestinal obstruction and blockage, and intervention and mesh removal surgery¿ with approximate dates of treatment as between (b)(6) 2018 and (b)(6) 2018.The ppf form also indicates the patient was implanted with a non-abbvie device, "bard phasix ¿ lot #unknown¿ during the (b)(6) 2018 procedure.The patient was implanted with another non-abbvie device, "acell gentrix surgical matrix plus ¿ lot #unknown¿ during the (b)(6) 2018 procedure.Neither of these non-abbvie devices have been removed or revised.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, 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: 18155048
• Report Number: 1000306051-2023-00270
• Device Sequence Number: 20450047
• Product Code: FTM
• UDI-Device Identifier: 00818410010362
• UDI-Public: 00818410010362
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 0808002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/11/2024
• 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: 65 YR
• Patient Sex: Male