MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE; MESH, SURGICAL

Catalog Number	0608001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/22/2016
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) 2016.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 sp100311 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.Additional and/or corrected data.
Event or Problem Description
This is follow up #1 to report on 18/feb/2024, pmqa received notification from legal that the plaintiff profile form (ppf).As per the ppf form, the patient underwent a repair of recurrent hiatal hernia with a reduction of intrathoracic omentum and gastric sleeve; diaphragmatic crural repair reinforcedand and patient was implanted with the strattice device lot# sp100311-133; ref.# 0608001 on (b)(6) 2016.On (b)(6) 2016, patient underwent ventral incisional hernia with primary closure and implanted with a non-abbvie device, onlay phasix mesh (bard phasix mesh lot #huat2166).On (b)(6) 2016, a subcutaneous seroma was drained and serosanguineous fluid aspirated.The form lists the condition that was treated: on (b)(6) 2017, an exploratory laparotomy and segmental small bowel resection.Approx.2016-2017, cat scans of ab/pel and mri diagnostic testing performed.Result was not provided.Between (b)(6) 2017, exploratory laparotomy and segmental small bowel resection performed.On (b)(6) 2017, pressed fluid out of seroma in office post-operatively.Between (b)(6) 2015 - 2016, follow up on hernia surgeries repair and symptoms.On (b)(6) 2017, expressed fluid (seroma from bowel obstruction) from incision in exam room.From 2017 - 2024, exploratory laparotomy and segmental small bowel resection, post-op seroma and gastric emptying test.On (b)(6) 2019, gastric emptying test performed.From (b)(6) 2022 - (b)(6) 2024, gastroparesis; hiatal hernia was noted.Approx.2016-present, stomach/abdominal pain; trouble keeping food down; muscle pain; body cramps; occasional nausea; hernia symptoms; hernia.Between (b)(6) 2025, stomach pain and vomiting; bowel obstruction.As reported in initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2016.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, 6CM X 8CM, PLIABLE
• 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: 21343865
• Report Number: 1000306051-2025-00018
• Device Sequence Number: 7959334
• Product Code: FTM
• UDI-Device Identifier: 00818410010003
• UDI-Public: (01)00818410010003(10)SP100311(11)151019(17)170930
• Combination Product (Y/N): N
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 09/30/2017
• Device Catalogue Number: 0608001
• Device Lot Number: SP100311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown