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); Adhesion(s) (1695); Hernia (2240)
Type of Reportable Event	Serious Injury
Event or Problem 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.
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.
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 sp100568 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.
Event or Problem Description
On (b)(6) 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 ¿incisional¿ hernia repair and was implanted with strattice device lot sp100568 on (b)(6) 2018.The patient underwent a ¿repair recurrent incisional hernia; reducible enterolysis (freeing of intestinal adhesion) (separate procedure) implantation of mesh for open incisional hernia repair 15 cm x 20 cm parietex¿ on (b)(6) 2019.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 ¿suffered from a wound infection and used a wound vac¿ and ¿wears an uncomfortable abdominal binder.¿ they have ¿difficulty playing golf, fishing, and performing household chores,¿ and are ¿dependent on others to help with the daily tasks [they have] difficulty completing [themselves].¿ the form lists the conditions that were treated were ¿paraoesophageal hernia; robot assisted laparoscopy, surgical; repair of paraoesophageal hernia, includes fundoplasty, when performed; without implantation of mesh toupet fundoplasty; extensive lysis of adhesions¿ with approximate dates of treatment between (b)(6) 2018 and (b)(6) 2018.From (b)(6) 2018 to (b)(6) 2018, patient also reported treatment of ¿perforation of viscus; exploratory laparotomy; possible small bowel resection; lysis of adhesions; possible mesh removal; wound vac.¿ over the same period, patient reported treatment of ¿wound infection after surgery; clear necrotizing infectious process associated with midline incision; debrided abdominal wall extensively, placed wound vac; belly opened for second look; reopening of recent laparotomy; debridement, abdomen; muscle and/or fascia (includes epidermis, and subcutaneous tissue, if performed); wound therapy, including topic application(s), assessment, instruction(s) for ongoing care, per session; total wound(s) surface are less than or equal to 50 square centimeters.¿ also over the same period, patient reported treatment of ¿necrosis of subcutaneous tissue; repair of small intestine leak; complex closure of abdominal wall using biologic mesh (strattice).¿ between 28/feb/2019 and 04/mar/2019, patient reported treatment of ¿recurrent incisional hernia repair recurrent incisional hernia; reducible enterolysis (freeing of intestinal adhesion) (separate procedure) implantation of mesh for open incisional hernia repair 15 cm x 20 cm parietex.¿ the ppf form also indicates the patient was implanted with a non-abbvie device, "proceed¿ on (b)(6) 2011.Patient was also implanted with another non-abbvie device ¿mesh composite parietex¿ on (b)(6) 2019.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.
Event or Problem Description
On 19/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 ¿incisional¿ hernia repair and was implanted with strattice device lot sp100568 on (b)(6) 2018.The patient underwent a ¿repair recurrent incisional hernia; reducible enterolysis (freeing of intestinal adhesion) (separate procedure) implantation of mesh for open incisional hernia repair 15 cm x 20 cm parietex¿ on (b)(6) 2019.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 ¿suffered from a wound infection and used a wound vac¿ and ¿wears an uncomfortable abdominal binder.¿ they have ¿difficulty playing golf, fishing, and performing household chores,¿ and are ¿dependent on others to help with the daily tasks [they have] difficulty completing [themselves].¿ the form lists the conditions that were treated were ¿paraoesophageal hernia; robot assisted laparoscopy, surgical; repair of paraoesophageal hernia, includes fundoplasty, when performed; without implantation of mesh toupet fundoplasty; extensive lysis of adhesions¿ with approximate dates of treatment between (b)(6) 2018.From (b)(6) 2018, patient also reported treatment of ¿perforation of viscus; exploratory laparotomy; possible small bowel resection; lysis of adhesions; possible mesh removal; wound vac.¿ over the same period, patient reported treatment of ¿wound infection after surgery; clear necrotizing infectious process associated with midline incision; debrided abdominal wall extensively, placed wound vac; belly opened for second look; reopening of recent laparotomy; debridement, abdomen; muscle and/or fascia (includes epidermis, and subcutaneous tissue, if performed); wound therapy, including topic application(s), assessment, instruction(s) for ongoing care, per session; total wound(s) surface are less than or equal to 50 square centimeters.¿ also over the same period, patient reported treatment of ¿necrosis of subcutaneous tissue; repair of small intestine leak; complex closure of abdominal wall using biologic mesh (strattice).¿ between (b)(6) 2019, patient reported treatment of ¿recurrent incisional hernia repair recurrent incisional hernia; reducible enterolysis (freeing of intestinal adhesion) (separate procedure) implantation of mesh for open incisional hernia repair 15 cm x 20 cm parietex.¿ the ppf form also indicates the patient was implanted with a non-abbvie device, "proceed¿ on (b)(6) 2011.Patient was also implanted with another non-abbvie device ¿mesh composite parietex¿ on (b)(6) 2019.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.
Additional Manufacturer Narrative
Corrected data: h4.

• 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: 17662438
• Report Number: 1000306051-2023-00204
• Device Sequence Number: 15225743
• 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: 2018
• 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: 08/31/2019
• Device Catalogue Number: 1620002
• Device Lot Number: SP100568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 08/21/2024
• Initial Report FDA Received Date: 08/31/2023
• 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: 11/07/2017
• 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: 66 YR
• Patient Sex: Male