MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAYWARD FLOSEAL HEMOSTATIC MATRIX; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 12/01/2009

Event Type  Injury  

Event Description

It was reported by the literature (palacios, diego a.Et.Al., ¿pilot study comparing the two hemostatic agents in patients undergoing partial nephrectomy.¿ bmc research notes 2013, 6:399) that three (3) patients experienced complications after a nephron sparing surgery in which floseal was used.Two (2) patients experienced reduced glomerulus filtration rate (gfr).One (1) patient experienced a non-urologic complication.This report reflects the patient that experienced a non-urologic complication.This is one of three reports.Abstract: background: recently studies have demonstrated improved outcomes in patients undergoing nephron-sparing surgery (nss) for low stage renal tumors, thus nss is widely accepted as the treatment option for these patients.With nss, there is a risk of renal hemorrhage and thus haemostatic agents may be routinely applied to the cut surface of the kidney.Herein we compare two commercially available haemostatic agents applied intra-operatively to the cut surface of the kidney.Post-operative outcomes (oncologic and non-oncologic) are reported.Methods: the medical records of 23 patients with suspicious renal mass documented on axial imaging and who underwent open nss via a mini-subcostal incision were extensively reviewed.One of two haemostatic agents (floseal, n = 11; arista, n = 12) was intra-operatively applied to the cut surface of the kidney.Chi-square and t- student test was used to compare outcomes between the cohort of 11 patients who had floseal and the 12 patients who had arista.Results: median pre-operative size of renal mass was 4.3 cm (range 1.5-7.0 cm).Final pathology revealed 3 oncocytomas and 20 renal cell carcinoma (17 clear cell, 1 chromophobe and 2 papillary), pt1a = 14 and pt1b = 6.Mean intra-operative blood loss and hospital stay between the flosealw vs.Arista cohorts did not significantly differ (227 ml vs.250 ml, p = 0.68 and 4.4 days vs.4.5 days, p = 0.76, respectively).Intra-operative and post-operative complications were not different between the two cohorts.No recurrences have been documented with a mean follow-up of 18 months.Conclusion: along with meticulous surgical technique, the use of either haemostatic agent (floseal or arista) was not associated with high rate of intra-operative or post-operative haemorrhage.Thus either haemostatic agent may be successfully used during nss.

Manufacturer Narrative

(b)(4).Additional case information was received from the author of the literature.It was reported the patient had a small apical pneumothorax that resolved on its own within a week or so.Baxter final medical assessment: based on follow-up information from the corresponding author of the publication this patient experienced a small pneumothorax that resolved spontaneously (air resorption) in about a week.This type of complications requires usually prolongation of the hospital stay, and by that it is considered a ¿serious injury¿.The nature of this complication allows us to exclude a causal association of the pulmonary complication (pneumothorax) with the renal application of floseal.As the case was determined to not be related to the use of floseal, the batch review and sample evaluation were not necessary.No trend was identified.The case will be kept on file for trending purposes.

Manufacturer Narrative

(b)(4).Baxter medical assessment summary: a non-urologic complication is defined in the publication of palacios et al.As a cardiac, gastrointestinal pulmonary, thromboembolic, incisional or other type of complication.Given this definition and multitude of complications included in this category and the lack of any useful clinical details, a causal association with the use of floseal cannot be determined.The reported case is not assessable.A follow-up report will be submitted upon receipt and evaluation of additional information.

• Brand Name: FLOSEAL HEMOSTATIC MATRIX
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 9454 5
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3602545
• MDR Text Key: 4070997
• Report Number: 2032282-2014-00027
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other