MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH C-QUR LITE CENTRIFX; MESH, SURGICAL, POLYMERIC

Model Number	31396
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch report (mw5114784) was received, home patients states: progressively worsening symptoms, including tightening along both sides of abdomen and tight pelvis, and pain sitting and bending over.Pain at locations of fasteners.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Medwatch report (b)(4) was received, home patients states: he had a bi-lateral sports hernia repair.Progressively worsening symptoms, including extensive inflammation, tightening along both sides of abdomen and tight pelvis, and pain sitting and bending over.Pain at locations of fasteners.
Additional Manufacturer Narrative
Investigation: this complaint was received through the fda's medwatch program.The medwatch report explains that a patient who was implanted with centri-fx mesh (model 31396, lot 440001) in (b)(6) 2019 was experiencing progressively worsening symptoms, including tightening along both sides of abdomen, a tight pelvis and pain sitting and bending over.The report explains the pain is at the locations of the fasteners.Additional information was obtained from the medwatch initial reporter who was also the patient.The patient indicated he had one of two implanted mesh panels explanted in (b)(6) 2023 due to the pain he was experiencing.Medical records related to the implant and explant procedures were provided along with pictures of the metallic tacks that were removed.Neither pictures of the explanted mesh nor the explanted mesh itself were provided for evaluation.Contemporaneous samples are not available for the lot 440001 as this lot expired in january 2021.The post explant procedure report provided by the patient indicates the operative findings as extensive inflammatory reaction to the mesh and multiple metallic tacks into the rectus muscle and oblique muscles with residual recurrent right inguinal hernia, which was indirect.The procedure removed all visible metallic tacks, the mesh panel implanted on the left side of the patient¿s body as well as a portion of the mesh that was implanted on the right side of the patient¿s body because it was overlapped with the left side.The patient indicated his condition has much improved since the explant procedure.A medical assessment was obtained.The medical assessment concludes that the unfortunate alleged injuries suffered by this patient are potentially multifactorial and an atrium mesh device was not the only attributing factor.The factors likely include but are not limited to, the patient¿s preoperative pain, large bilateral hernias, bilateral adductor longus injury, surgical technique, and patient¿s foreign body reaction.A review of the device history records going back to the coated c-qur fx sheet sub assembly level shows that there were no non-conformances noted and the product met all quality and performance requirements.There is no evidence that procedural or specification changes that occurred within a year before or after the lot was produced could be related to the complaint.Based on the details provided, it does appear the device was used in accordance with the labeled indications for use.The ifu discloses a number of adverse reactions, including pain and the need for surgical revision, that can occur due to the use of surgical mesh.There is no indication of a nonconformity existing with the product.The physician notes from the medical records obtained indicate an inflammatory reaction to the mesh and the metallic tacks used to hold the mesh in place.After removal of the mesh and tack, the patient reported a much improved condition.A second mesh panel from the same lot that the removed mesh panel was from remains in the patient without reported incident.A definitive root cause cannot be determined however, the reported pain and need for surgical revision are recognized and anticipated complications associated with the use of surgical mesh.A risk review found that the hazard/harm (reported defect) and associated severity is adequately addressed in the product's risk management file.H3 other text : device not available for return.

• Brand Name: MESH C-QUR LITE CENTRIFX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16461532
• Report Number: 3011175548-2023-00071
• Device Sequence Number: 6573137
• Product Code: FTL
• UDI-Device Identifier: 00650862313963
• UDI-Public: 00650862313963
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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: 01/16/2021
• Device Model Number: 31396
• Device Catalogue Number: 31396
• Device Lot Number: 440001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/11/2023; 04/14/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/17/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male