MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number	1620002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
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 firm on (b)(6) 2021.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.
Event or Problem Description
This is follow up#1 to report on 20/oct/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¿ repair and was implanted with strattice device lot; sp200227; ref#: (b)(4) on (b)(6) 2021.The patient underwent an ¿exploratory laparotomy, partial colectomy, closure of ileostomy, explanted infected mesh, with tap block¿ on 11/aug/2021.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, and economic and non-economic losses.¿ patient ¿has been hospitalized and undergone multiple surgical procedures¿ and ¿has suffered from wound infections.¿ patient and spouse have also ¿changed the dressings and packed/repacked [their] open wound.¿ they have ¿lifting restrictions and had to adjust [their] physical activities,¿ ¿difficulty with balance and core strength exercises,¿ ¿difficulty swimming, biking, and making wing and jelly from [their] homegrown grapes.¿ they are ¿dependent on others to help with the daily tasks [they have] difficulty completing [themselves].¿ patient ¿is unable to lift [their] grandchildren/great-grandchildren or participate in physical activities with them without experiencing pain.¿ patient ¿is fearful [they] will suffer from another hernia in the future¿ and claims ¿these injuries contributed to [their] depression and anxiety.¿ the form lists the conditions that were treated were ¿open abdomen status post ileocecal resection; abdominal washout with creation of ileostomy, wound closure, repair ventral hernia with mesh, creation mucus fistula; rule out sbo and sepsis (strattice implant)¿ with approximate dates of treatment between (b)(6) 2021 and (b)(6) 2021.From approximately march 2021 to may 2021, patient was in ¿rehab.¿ between approximately may 2021 and july 2021, patient was in ¿home health care; wound care; physical therapy.¿ from 11/aug/2021 to 20/aug/2021, patient received treatment of ¿perforation of colon exploratory laparotomy, partial colectomy, closure of ileostomy, explanted infected mesh, with tapp block; intra-abdominal abscess with infected hernia mesh.¿ between (b)(6) /2021 and (b)(6) 2021, patient received treatment for ¿sepsis; hypo-osmolality and hyponatremia; diarrhea; other elevated white blood cell count.¿ from 2020 to 2022, patient received treatment for ¿depression & anxiety.¿ in july 2022, patient received treatment for ¿bowel blockage.¿ in december 2022, patient received treatment for ¿exploratory; mesh and scar tissue removal.¿ on (b)(6) 2023, patient received treatment of ¿hernia surgery.¿ the ppf form also indicates the patient was implanted with a non-abbvie device, "ethicon prolene mesh¿ lot pbh883 on (b)(6) 2020.This was revised on (b)(6) 2021 for ¿abdominal washout with creation of ileostomy, wound closure, repair ventral hernia with mesh, creation mucus fistula.¿ on (b)(6) 2018, patient underwent ¿exploratory laparotomy, partial colectomy, closure of ileostomy, explanted infected mesh, with tapp block.¿ as reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2021.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.A review of the device history record for strattice lot sp200227 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.No strattice devices were returned for evaluation.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.Additional, changed, and/or corrected data: a.2., b.5., d.4., d.6b., h.4., h.6.
Additional Manufacturer Narrative
Corrected data: h4.
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2021.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, 16 X 20, 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: 17439258
• Report Number: 1000306051-2023-00173
• Device Sequence Number: 2905508
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• 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: 2021
• 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,Followup
• Report Date (Section B): 08/27/2024

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 1620002
• Device Lot Number: SP200227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 08/21/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/24/2023; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female