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

Device Problem Insufficient Information (3190)

Patient Problem Thromboembolism (2654)

Event Date 01/01/2009

Event Type  Injury  

Event Description

Patient 3 of 5: it was reported from a literature that five (5) patients experienced pulmonary embolism (pe) after an intracranial tumor resection in which floseal was used.This is one (1) of five (5) reports.From literature: safaee, michael et.Al.,¿use of thrombin-based hemostatic matrix during meningioma resection: a potential risk factor for perioperative thromboembolic events.¿ clinical neurology and neurosurgery http://dx.Doi.Org/10.1016/j.Clineuro.2014.01.021 abstract: objective: hemostatic agents are widely used in patients undergoing intracranial tumor resection to facilitate local hemostasis.We hypothesized that systemic activation of the clotting cascade after local application of hemostatic agents may result in unintended thromboembolic events, including deep venous thrombosis (dvt) and pulmonary embolism (pe).We performed a retrospective analysis to identify potential associations between hemostatic agent use and dvt/pe.Methods: a single-institution review of patients undergoing surgical resection of cranial meningiomas was performed.Patient demographics including gender and bmi, procedure duration, estimated blood loss (ebl), tumor pathology, use of hemostatic matrix, and the presence of dvt/pe within 14 days of surgery were collected from the medical record.Results: a total of 467 patients underwent a craniotomy for meningioma from 2009- 2012.There were 331 women and 136 men with a mean age of 58 ± 14 years (range 18-92) and mean bmi of 28 ± 6.Tumor pathology included 359 grade i, 77 grade ii, and 31 grade iii tumors.There were 12 patients (2.6%) with thromboembolic events.Age (p=0.66), gender (p=0.33), ebl (p=0.99), and procedure duration (p=0.17) were not associated with an increased incidence of dvt/pe.Use of dvt prophylaxis initiated 72 hours after surgery did not significantly alter the incidence of dvt/pe (p=0.20).Body mass index (p=0.04) and tumor grade (p=0.05) were associated with increased incidence of dvt/pe.Patients receiving greater than 10 ml of a hemostatic agent intraoperatively had an increased incidence of dvt/pe (p=0.02).In a multivariate model, both bmi (or=1.07, 95% ci: 1.00-1.15, p=0.048) and use of more than 10 ml of hemostatic agent (or=8.03, ci: 1.02-63.40, p=0.048) were found to be significantly associated with the risk of dvt/pe.Conclusion: hemostatic agents are valuable tools in modern neurosurgery, however their use may be associated with an increased risk of dvt/pe in patients undergoing meningioma resection.This finding provides the impetus for more definitive clinical and laboratory studies to characterize the biology of this association and helps identify patients at increased risk for thromboembolism.This study also affirms the association between high bmi and the risk of thromboembolism.Interestingly the use of prophylactic anticoagulation after surgery did not decrease the incidence of dvt/pe.

Manufacturer Narrative

(b)(4).Baxter medical assessment: from a retrospective, peer-reviewed publication on use of floseal for hemostasis in meningioma surgery in 467 patients (for reference see case narrative) 12 patients have been reported to have developed thromboembolic events (deep vein thrombosis ¿ dvt, and/or pulmonary embolism ¿ pe) in the first two weeks post surgery.The incidence of thromboembolic events in this retrospective review has been 2.6%, which compares favorably to previous studies.In patients undergoing craniotomy for tumor resection, reported thromboembolism rates range from 3-26%, even with prophylaxis.Additional follow up clarification with the corresponding author of this publication clarified that 5 patients experienced a dvt, another five a pe, and two patients developed both a dvt and pe.This medical assessment relates to the five cases of pulmonary embolism (pe).A systemic interaction of floseal, as speculated in the publication, that may increase the risk of hypercoagulability in the first 14 days after surgery can be excluded, since the thrombin in the composition of floseal reacts with the patient¿s fibrinogen to form a clot within 60-120 seconds after application.Even if inadvertently injected in the vascular system, this reaction will occur in close temporal relationship (within a few minutes) with the product application.Since we are not able to determine the latency from floseal application till the occurrence of the pe, and since floseal is applied in the immediate vicinity of the vascular system, one cannot exclude that the floseal application has contributed to the reported pulmonary embolism.For the reported five events of pulmonary embolism (pe) without accompanying dvt we cannot exclude a causal association with the use of floseal.A follow-up report will be submitted upon completion of manufacturer's investigation.

Manufacturer Narrative

(b)(4).Baxter (b)(4).Completed the investigation.As no sample or lot number was provided, sample evaluation and batch review could not be performed.No trend was identified.Per hayward, the affected product lot is unknown thus the batch record review and retention sample evaluation could not be performed.No further investigation is required.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: 3636984
• MDR Text Key: 4178088
• Report Number: 2032282-2014-00039
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• 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: 03/21/2014
• 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