MAUDE Adverse Event Report: BRANCHBURG MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2); MESH, SURGICAL

Catalog Number	CON2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with 1st strattice on (b)(6) 2017 and 2nd 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.This is the same event and the same patient reported under patient identifier (b)(6) (emdr-20055).This emdr is being submitted for the 1st strattice.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp100512 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.
Event or Problem Description
This is follow up #1 to report on 26/mar/2024, 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 strattice device on (b)(6) 2017.The patient underwent an ¿open repair of recurrent incisional hernia using component separation technique and two types of mesh¿ on (b)(6) 2018.The patient was then implanted with another strattice device.The patient underwent an ¿open repair of recurrent incarcerated incisional hernia; explantation of infected mesh; excision of atrophic skin; release of subcutaneous flaps and advancement; extensive lysis of adhesions¿ on (b)(6) 2019.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, adhesions, infection, wound/wound vac, intervention and removal surgeries.¿ the form lists the conditions that were treated were ¿pain; recurrence; infection; wound/wound vac; intervention and removal surgeries¿ with approximate dates of treatment between (b)(6) 2017 and (b)(6) 2018.The patient also was treated for ¿pain; recurrence; adhesions; infection; intervention and removal surgeries¿ on or about (b)(6) 2019.The ppf form also indicates the patient was implanted with a non-abbvie device, ¿bard ventrio ¿ lot #huzk0154¿ on (b)(6) 2017.The form indicates that this device was removed on (b)(6) 2017 due to ¿exploratory laparotomy and removal of infected mesh.¿ the patient was implanted with another non-abbvie device, ¿bard mesh flat sheet ¿ lot # 0112660¿ on (b)(6) 2018.The form indicates that this device was removed on (b)(6) 2019 due to ¿open repair of recurrent incarcerated incisional hernia; explantation of infected mesh; excision of atrophic skin; release of subcutaneous flaps and advancement; extensive lysis of adhesions.¿ the patient was implanted with a third non-abbvie device, ¿covidien parietene macroporous¿ on (b)(6) 2020.The form indicates that this device was removed on (b)(6) 2020 due to ¿robotic lysis of adhesions; robotic explantation of old infected mesh¿ and revised on (b)(6) 2021 due to ¿open repair of recurrent incisional hernia with incarceration; excision of atrophic skin; lipocutaneous flap advancement.¿ as reported in the initial: limited information was reported through a legal event that a patient was implanted with 1st strattice on (b)(6) 2017 and 2nd 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.This is the same patient reported under patient identifier (b)(6).(emdr-20055).This emdr is being submitted for the 1st strattice.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• 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: 18681738
• Report Number: 1000306051-2024-00049
• Device Sequence Number: 13768274
• Product Code: FTM
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 02/28/2019
• Device Catalogue Number: CON2006
• Device Lot Number: SP100512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male