MAUDE Adverse Event Report: BRANCHBURG 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 Code	Hernia (2240)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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 and (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 (b)(6) 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 and (b)(6) 2021.The patient also underwent a ¿parastomal hernia repair with biologic mesh placement¿ with approximate dates of treatment between (b)(6) 2022 and (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 (b)(6) 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 device was revised on (b)(6) 2022 during ¿parastomal hernia repair with biologic mesh.¿ this is the same patient reported under patient identifier (b)(6).This mdr is being submitted for the second strattice implanted on (b)(6) 2021.
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 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Common Device Name: 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; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18764472
• Report Number: 1000306051-2024-00055
• Device Sequence Number: 7701751
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 1620002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/22/2024
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female