MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Granuloma (1876); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Article title: can near-infrared imaging distinguish a gelatin-based matrix granuloma from a malignancy in a kidney? authors: burak koseoglu, ali yasin ozercan, aysel colak, serdar basboga & altug tuncel citation: minimally invasive therapy & allied technologies, doi: 10.1080/13645706.2023.2272968.This study presents a case of a 62-year-old male patient who underwent transperitoneal laparoscopic renal cyst decortication eight years earlier for benign renal cyst of 5 cm in diameter located in the lower pole of the left kidney.His previous surgical records revealed that a gelatin-based hemostatic matrix (surgiflo) had been used on the base of the surgical site to provide efficient hemostasis.Reported complications include left lumbar pain.Contrast-enhanced abdominal ct imaging revealed a bosniak type-4 cyst of 4cm in diameter, presenting with a semi-solid component at the previous surgical site (figure 1a).In conclusion, it is important to consider the possibility of a foreign body granuloma from surgiflo, which may mimic a neoplastic kidney lesion in radiological appearance in similar cases.Clinicians should also be aware that nirf imaging with icg may not contribute to distinguishing gelatin-based matrix granulomas from kidney cancer since they have similar fluorescence patterns.The adverse event originates from a case study in an article.It is not clear if the used product was surgiflo with or without thrombin.Conservatively it is entered as surgiflo with thrombin (ms0012).Follow-up questions are forwarded to the reporter to clarify.The case appears to be off-label since the product was visible after the surgery (the product was not removed after hemostasis was achieved).This article states that a foreign body granuloma resulting from surgiflo residue can be mistaken for kidney cancer.An evaluation is performed by a clinical evaluator: it is well known among surgeons that organic or inorganic material, deliberately or accidentally left in a patient during surgery (e.G.Hemostatic agents, implants, sutures), can lead to the formation of a foreign body granuloma.These are completely harmless processes, which are usually not confused with neoplasms (benign or malignant), and which only require treatment if they are symptomatic, often in the form of excision.Therefore, as a surgeon, one would expect that if a postoperative scan shows a space-occupying process so late in the course (fx.After 8 years as described in the article) that a hematoma can be excluded, and it is a granuloma or possibly a recurrence of a cyst or solid tumor if this was the indication for the primary surgery.A de novo arising malignant tumor in the surgical cavity will be an extremely rare event.As stated, treatment will be directed according to the patient's possible symptoms, and a scan (mri or ct with contrast) will usually be able to visualize not only the problem but also provide guidance for further treatment.One comment should be made on the article cited.It is of low quality with errors in the illustrations, lacking crucial references and describes the use of a surgical technique that is unnecessary and prolongs the operation time, thereby increasing the risk to the patient.In the ifu it is stated that: - "only the minimum amount of surgiflo¿ needed to achieve haemostasis should be used.Once haemostasis is achieved, any excess surgiflo¿ should be carefully removed." - "foreign body reactions, encapsulation of fluid, and haematoma have been observed at implant sites." as the risk of granuloma after previous surgery is common knowledge by surgeons, and the ifu includes a warning of the risk of foreign body reactions including granuloma, it is evaluated, that no more information towards the surgeons/users is needed.

• Common Device Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, ; DA
• MDR Report Key: 18182003
• Report Number: 3008478369-2023-00016
• Device Sequence Number: 12699332
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown