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

Catalog Number 1016002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 06/15/2021

Event Type  Injury  

Event 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.

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 an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, 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 Description

This is follow up#1 to report on 02/feb/2024, pmqa received notification from legal that the plaintiff profile form.Patient was implanted with strattice on (b)(6) 2018.As per the ppf form, the patient underwent a ¿parastomal hernia¿ surgery and was implanted with 1st strattice device with catalog number 1016002 on (b)(6) 2018.On (b)(6) 2021, the patient underwent a ¿parastomal hernia¿ surgery and was implanted with a second strattice device with catalog number 1620002.On (b)(6) 2022, the patient underwent a ¿parastomal hernia¿ surgery and was implanted with a third strattice device.The patient underwent an ¿exploratory laparotomy with adhesiolysis > 3 hrs, repair of parastomal hernia with strattice mesh, partial colectomy with end colostomy, excision of mesh¿ on (b)(6) 2021.The patient next underwent a ¿parastomal hernia repair with biologic mesh¿ on (b)(6) 2022.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, physical injury, scarring, disfigurement.¿ patient ¿has been hospitalized and undergone multiple surgical procedures.¿ ¿it takes [the patient] longer to complete daily tasks and [patient] is dependent on others to help with daily tasks [they have] difficulty completing [themselves].¿ patient ¿has lifting restrictions and has had to adjust [their] physical activities.¿ patient ¿has difficulty bending, walking long distances, dancing, and doing yard work.¿ patient ¿is fearful that [they] will suffer another hernia in the future.¿ the form lists the conditions that were treated were ¿parastomal hernia without obstruction or gangrene, completion proctectomy, small bowel serosal injury x 1, lysis of extensive adhesions, open parastomal hernia repair with mesh placement, rectal prolapse¿ with approximate dates of treatment between (b)(6) 2018.The patient also underwent treatment for ¿egd trachealization of esophagus, barrett¿s esophagus, ge junction, hiatal hernia, multiple gastric polyps, gastritis¿ on or about (b)(6) 2018.The patient subsequently underwent treatment for ¿stoma pain, small hiatal hernia, reflux, fatigue, medication management¿ on or about (b)(6) 2018.The patient underwent treatment for ¿difficulty with pouching stoma¿ on or about (b)(6) 2018.The patient received treatment for ¿diaphragmatic/hiatal hernia w/ gerd¿ on or about (b)(6) 2019.The patient underwent ¿fl esophagram, moderate sliding hiatal hernia with gerd¿ on about (b)(6) 2019.The patient received an ¿egd - retroflexion showed again a loose wrap, no longer effective and then possible hiatal hernia recurrence, herniation of stomach through a diaphragmatic hernia¿ on or about (b)(6) 2019.The patient next underwent a ¿fluoroscopy esophagram -persistent moderate sliding type hiatal hernia marked with esophageal reflux¿ on or about 08/jan/2020.The patient underwent treatment for ¿worsening abdominal pain and decreased ostomy output, incarcerated parastomal hernia with obstruction, exploratory laparotomy with adhesiolysis > 3 hours, repair of parastomal hernia with strattice mesh, partial colectomy with end colostomy, excision of mesh¿ with approximate dates of treatment between (b)(6) 2021.The patient also underwent a ¿parastomal hernia repair with biologic mesh placement¿ with approximate dates of treatment between (b)(6) 2022.The ppf form also indicates the patient was implanted with a non-abbvie device, "proceed mesh, lot #cmg553¿ on (b)(6) 2011.The form indicates that this device was removed on 21/oct/2015 during treatment for ¿small bowel adhesions throughout the abdomen and pelvis, previous incisional hernia mesh removed, very deep cul de sac and redundant colon.¿ the ppf form indicates the patient was implanted with another non-abbvie device, ¿flexhd thick acellular dermis allograft hydrate, model #471307¿ on (b)(6) 2016.The form indicates that this device was revised on (b)(6) 2018 during ¿open parastomal hernia repair with mesh placement.¿ the device was subsequently revised on (b)(6) 2021 during ¿exploratory laparotomy with adhesiolysis > 3 hrs., repair of parastomal hernia with strattice mesh, partial colectomy with end colostomy, excision of mesh.¿ the device was also revised on (b)(6) 2022 during ¿parastomal hernia repair with biologic mesh.¿ this is the same patient reported under patient identifier (b)(6) (emdr-21574).This mdr is being submitted for the second strattice implanted on (b)(6) 2021.As reported in the initial: 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.

Manufacturer Narrative

Additional, changed, and/or corrected data: a.2., b.5., g.1., h.6.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; building 3; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18360313
• MDR Text Key: 330933289
• Report Number: 1000306051-2023-10021
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1016002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/22/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female