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

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Electrolyte Imbalance (2196)

Event Date 09/01/2011

Event Type  Injury  

Event Description

It was reported by a literature (liebelt, david a.Et al.¿effects of intraoperative use of the topical hemostatic matrix agent, floseal, in primary unilateral total knee arthroplasty.¿ current orthopaedic practice volume 24 number 4 september/october 2013.) that two (2) patients experienced pulmonary embolus.This is one of two reports.Abstract: background - total knee arthroplasty can result in blood loss severe enough to require postoperative blood transfusions.Minimizing blood loss perioperatively is therefore essential to minimize morbidity in patients undergoing total knee arthroplasty.Floseal (baxter international, inc., (b)(4)) is a topical hemostatic matrix agent used for hemostasis during surgical operations.Methods - patients undergoing routine total knee arthroplasty were randomized into two groups.One group received intraoperative standard hemostatic therapy and another group received intraoperative standard hemostatic therapy as well as floseal.The groups were compared based on 24-hour postoperative drain output, 3-day postoperative drop in hematocrit and hemoglobin levels, and the incidence of postoperative transfusions.Results - one hundred and forty patients with primary unilateral total\ knee arthroplasties were recruited and 70 were randomized to the control group and 70 to the floseal group.The mean 24-hour postoperative drain output for patients in the control group was 457.1 (þ/ 28.60) ml compared with 405.0 (þ/ 22.93) ml in the floseal group.This difference was not significant (p¼0.1651).Comparison of 3-day postoperative drops in hemoglobin and hematocrit values between the control and experimental groups also demonstrated no statistical significance (p¼0.5422 and p¼0.6524, respectively).The incidences of postoperative blood transfusions based on intraoperative use of floseal were not significantly different (p¼0.4389).Perioperative complications and their rates were not found to be changed with the intraoperative use of floseal.Conclusions - our data suggest that there is no benefit from the regular use of floseal in routine total knee arthroplasty.Intraoperative use of floseal in total knee arthroplasty did not increase complications and can likely be used safely.

Manufacturer Narrative

(b)(4).Baxter medical assessment: pulmonary embolism is a well-known complication after surgery, and specifically after total knee arthroplasty (deep vein thromboses).Although a causal relationship of the floseal use with the reported complication is not implied, and the reported incidence in the publication is comparable with the complication rate in the control group and in routine clinical practice, we cannot exclude migration of floseal into the venous system of the lower extremity, and subsequently into the lung circulation.Therefore a causal association with the use of floseal is possible.A follow-up report will be submitted upon receipt and evaluation of additional information.

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.No sample or lot number was provided therefore the sample evaluation and batch review could not be performed.Per hayward, no further investigation is required as the affected product lot was unknown and the batch record review and retention sample evaluation could not be performed.Furthermore, complaints alerted over the past twelve months for the complication of pulmonary embolism after a tka procedure has been reviewed and no additional complaint reported.This case will be kept on file for trending purposes.

• 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 94545
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3610789
• MDR Text Key: 4170373
• Report Number: 2032282-2014-00032
• 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: Study,Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• 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: 03/05/2014
• 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