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

Catalog Number	2020002
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2021
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 firm on (b)(6) 2012.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 13/aug/2025, 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 on (b)(6) 2021.The patient underwent a ¿lysis of adhesions¿ and ¿ventral hernia repair, implant of surgisis biologic mesh¿ on (b)(6) 2022.The patient underwent an ¿i & d of the abdominal wall abscess¿ on (b)(6) 2022.The patient underwent an ¿i & d of abdominal wall abscess¿ on (b)(6) 2022.The patient underwent a ¿ct guided abscess drainage, and aspiration of the left para midline abdominal wall fluid, cutaneous fistula expressed¿ on (b)(6) 2023.The patient underwent an ¿open excision of abdominal wall foreign body, suture and mesh excision, debridement of infected mesh¿ on (b)(6) 2023.The patient underwent a ¿deep absorbable suture removal, deep serous drainage, debridement¿ on (b)(6) 2023.The patient underwent an ¿open repair of recurrent incarcerated incisional hernia, open placement of mesh, bilateral myofascial advancement flap, open revision of wound, explantation of mesh, complex layer closer of complex wound¿ on (b)(6) 2024.The patient underwent an ¿i & d of deep abscess, necrotic tissue debrided¿ on (b)(6) 2024.The form lists the conditions that were treated were ¿repair of ventral hernia with biologic mesh (strattice), biopsy of left retroperitoneal mass and chemo denervation of abdominal wall¿ between (b)(6) 2021 and (b)(6) 2021.The patient was then treated for ¿bulging of left abdominal wall and pain; recurrent diastasis of left abdominal wall¿ between (b)(6) 2022.The patient underwent ¿ventral hernia repair, implant of biological mesh (surgisis implant)¿ between (b)(6) 2022.The patient received ¿lysis of adhesions¿ between (b)(6) 2022.The patient also received treatment for ¿surgical site infection¿ on or about (b)(6) 2022.The patient received ongoing treatment for ¿recurrent abdominal bulging and pain; surgical site infection¿ between (b)(6) 2022.The patient was treated for ¿abdominal pain; ct abd/pel small abscess in the left upper abdomen and small subcutaneous fluid collection¿ between (b)(6) 2022.The patient was seen for ¿persistent/worsening abdominal pain, nausea, vomiting¿ between (b)(6) 2022.The patient underwent ¿incision and drainage of the abdominal wall abscess; wound vac placement¿ between (b)(6) 2022.The patient was seen for ¿right-sided abdominal pain; silver nitrate applied in tract between 2 draining areas; (b)(6) 2022 ct scan demonstrates a couple of fluid collections in the area of the umbilicus¿ on or about (b)(6) 2022.The patient received reoccurring treatment for ¿hernia symptoms, abdominal pain, er visits¿ from approximately 2022 to present.The patient had reoccurring ¿follow-up of hernia surgical site infection, wound and medication management for infection, preventative medication management, diagnostic testing¿ from approximately 2023 to present.The patient had ongoing treatment for ¿anxiety and depression¿ from approximately 2010 to present.The patient also had ongoing treatment for ¿hernia surgeries; abdominal wall reconstruction; follow-up care¿ from 2023 to present.The patient underwent ¿incision and drainage of abdominal wall abscess; partial removal of mesh, wound vac placement¿ between (b)(6) 2022.The patient was seen for ¿hernia symptoms, revisions¿ between 2022 and 2024.The patient received ¿home health, wound management; wound vac management, dressing changes¿ post-surgeries in 2021 and 2022.The patient was treated for ¿abdominal pain, chest pain, anxiety¿ on or about (b)(6) 2023.The patient was treated for ¿post-op infection, abdominal pain to wound¿ on or about (b)(6) 2023.The patient received treatment for ¿abdominal pain, intermittent drainage from wound; (b)(6) 2023 us of abdominal wall fluid collection at the mid abdominal wall adjacent to the scar tissue¿ between (b)(6) 2023.The patient was seen for ¿chronic abdominal pain; ct guided percutaneous irrigation and aspiration of the left para midline abdominal wall fluid (infection noted); cutaneous fistula expressed¿ on or about (b)(6) 2023.The patient received treatment for ¿chest pain and abdominal wall pain; ct scan large ventral hernia containing non-obstructed loops of small and larger bowel¿ on or about (b)(6) 2023.The patient sought treatment for ¿concerned of retained mesh material in abdominal wall, which is chronically infected, which has led to the development of fistula/sinus tract¿ on or about (b)(6) 2023.The patient underwent ¿open excision of abdominal wall foreign body, suture, and mesh excision; debridement of infected mesh¿ between (b)(6) 2023 and (b)(6) 2023.The patient had ¿deep absorbable sutures removal; deep serous drainage with mild cloudy fluid; debridement¿ on or about (b)(6) 2023.The patient underwent ¿superficial debridement and dressing change¿ on or about (b)(6) 2023.The patient underwent an ¿open repair of recurrent incarcerated incisional hernia, open placement of mesh, bilateral myofascial advancement flap, open revision of wound, explantation of mesh, complex 3- layer closure of 20 cm complex wound (progrip implant)¿ between (b)(6) 2024 and (b)(6) 2024.The patient was treated for ¿abdominal/incision site pain; post-op surgical site abscess¿ between (b)(6) 2024.The patient received treatment for ¿abdominal pain, and drainage from midline wound; post-op surgical abscess; (b)(6) 2024 i & d of deep abscess; necrotic tissue debrided¿ between (b)(6) 2024.The patient had a ¿small sinus debrided¿ on or about (b)(6) 2024.The patient was treated for ¿increased abdominal pain and vomiting¿ between (b)(6) 2024.The patient was treated for ¿abdominal pain, nausea/vomiting, small amount fluid collection in abdominal wall; u/s not amendable to aspiration/drainage¿ between (b)(6) 2024.The patient underwent ¿ablation svt¿ on or about (b)(6) 2024.The patient was treated for ¿abdominal pain, vomiting¿ on or about (b)(6) 2024.The patient received treatment for ¿abdominal pain, nausea, residual inflammation around mesh¿ on or about (b)(6) 2025.The ppf form also indicates that the patient was implanted with an unknown non-abbvie device in approximately 2015.The device was revised on (b)(6) 2021 due to ¿repair of ventral hernia with biological mesh (strattice), biopsy of left retroperitoneal mass and chemo denervation of abdominal wall.¿ the device was subsequently revised on (b)(6) 2022 due to ¿lysis of adhesions, ventral hernia repair, implant of surgisis biologic mesh.¿ the patient was implanted with a second non-abbvie device, ¿cook surgisis¿ on (b)(6) 2022.The device was revised on (b)(6) 2022 due to ¿i & d of the abdominal wall abscess.¿ the device was further revised on (b)(6) 2022 due to ¿i & d of abdominal wall abscess.¿ the device was also revised on (b)(6) 2023 due to ¿ct guided abscess drainage, and aspiration of the left para midline abdominal wall fluid, cutaneous fistula expressed.¿ the device was subsequently revised on (b)(6) 2023 due to ¿open excision of abdominal wall foreign body, suture and mesh excision, debridement of infected mesh.¿ the device was further revised on (b)(6) 2023 due to ¿deep absorbable suture removal, deep serous drainage, debridement.¿ the device was revised on (b)(6) 2024 due to ¿open repair of recurrent incarcerated incisional hernia, open placement of mesh, bilateral myofascial advancement flap, open revision of wound, explantation of mesh, 10 complex layer closer of complex wound.¿ the patient was implanted with a third non-abbvie device, ¿progrip self-griping polypropylene mesh,¿ on (b)(6) 2024.The device was revised on (b)(6) 2024 due to ¿i & d of deep abscess, necrotic tissue debrided.¿ as reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2012.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
A review of the device history record for strattice lot sp200258 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.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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: terry ingram ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 21610507
• Report Number: 1000306051-2025-00036
• Device Sequence Number: 15359878
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: (01)00818410010140(10)SP200258(11)201030(17)220930
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/03/2025

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: 09/30/2022
• Device Catalogue Number: 2020002
• Device Lot Number: SP200258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female