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

Model Number 2994

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Sepsis (2067); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

(b)(4): patient 5 of potentially 5.It is presently unknown, but considered unlikely, that the complications are linked to the use of surgiflo.It is presently unknown whether the patients who experienced complications have fully recovered.

Event Description

Laparoscopic partial nephrectomy following tumor embolization in a hybrid room.Feasibility and clinical outcomes, panayotopoulos p.Et al.; surg oncol.2017 dec;26(4):377-381.Doi: 10.1016/j.Suronc.2017.07.012.Epub 2017 jul 29.Feasibility and morbidity of clampless laparoscopic technique with zero ischemia in partial nephrectomy, was evaluated in this prospective study of 50 consecutive patients between may 2015 and january 2017.Perioperative data, postoperative complications, surgical margin and modification of renal function one month after surgery was assessed.All laparoscopy guided partial nephrectomies were performed by a single surgeon, and prior to the surgical tumor resection, an interventional radiologist had ultra-selectively embolized the tumor vessels.The laparoscopic procedure was performed without individuating the renal pedicle.The tumor enucleation was performed without arterial bleeding and control of venous bleeding was carried out by applying a hemostatic agent (floseal© baxter, deerfield, il or surgiflo©, ethicon, somerville, nj).The authors conclude that clampless laparoscopic partial nephrectomy in a hybrid operating room without pedicular dissection after previous tumoral embolization is a technically safe and carcinologically efficient mini-invasive alternative for the management of localized renal tumors.The study states 5 postoperative complications, whereof 4 is described: 2 were of clavien-dindo grade i (isolated fever and varicose ulcer in a lower limb) and 2 were of grade ii (transfusion and non-urologic sepsis treated by antibiotics).No further description of the complications is given, and neither elaborates on whether the listed complications is per one individual, respectively.Hemostasis was managed by either floseal or surgiflo in 90% of cases (45 out of 50 patients), however, it is unknown whether surgiflo was used in the patients experiencing complications.In general, partial nephrectomies suffers from high perioperative morbidity as arterial clamping induces temporary renal ischemia, long operative time, peroperative blood loss, urinary fistulae and secondary bleedings.The complications listed in this study are expected to be common to partial nephrectomy or impaired renal function, however, complications are often of a higher clavien grade (laparoscopic and open partial nephrectomy: complication comparison using the clavien system, reifsnyder j, et al., jsls.2012 jan-mar; 16(1): 38-44.And complications of laparoscopic partial nephrectomy in 200 cases, ramani a.Et al, j urol.2005 jan;173(1):42-7.).This study evaluates a new method using super-selective arterial embolization performed in a hybrid or which allows tumor resection while avoiding vascular clamping, thus limiting peroperative and secondary bleedings.The authors themselves state that "no major perioperative or postoperative complications occurred", and that the procedure "is a safe and reproducible minimally invasive procedure for the treatment of localized renal tumors", which supports that no out of the ordinary complications had occurred.It is therefore considered unlikely that the minor complications observed are linked to the use of surgiflo, however, it cannot be excluded based on the present, limited, information.

• Brand Name: SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
• Type of Device: SURGIFLO® HEMOSTATIC MATRIX KIT W. THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: sydmarken 5; soeborg, 2860
• MDR Report Key: 11855156
• MDR Text Key: 265795590
• Report Number: 3008478369-2021-00016
• Device Sequence Number: 1
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P990004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other