FDA Adverse Event Injury Summary report: N

FLOSEAL MATRIX HEMOSTATIC SEALANT

MDR report key: 470039 · Received July 2, 2003

Report

Report Number
2954761-2003-00006
Event Type
Injury
Date Received
July 2, 2003
Report Date
June 5, 2003
Manufacturer
BAXTER HEALTHCARE CORP.
Product Code
LMF
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ON AN UNKNOWN DATE A PATIENT WITH A HISTORY OF SIGNIFICANT CORONARY ARTERY DISEASE (REFER TO THE MEDICAL HISTORY FIELD) UNDERWENT A FIVE VESSEL CABG. THE CROSS-CLAMP TIME WAS 86 MINUTES AND THE BYPASS TIME WAS 163 MINUTES. TO ACHIEVE HEMOSTASIS, ONE FLOSEAL KIT, WHICH CONTAINS 5000 UNITS OF THROMBIN JMI, WAS APPLIED TOPICALLY TO THE SURGICAL WOUND AT THE TIME OF CLOSURE. THE PATIENT WAS EXTUBATED ON POST-OPERATIVE DAY (POD) #1, AND CHEST TUBES AND PACING WIRES WERE REMOVED ON POD #2. ON POD #4, THE PATIENT'S PT AND PTT WERE APPROXIMATELY NORMAL. HOWEVER, THE PT AND THE PTT BEGAN TO RISE ON POD #7, AND REMAINED HIGH FOR AT LEAST 10 DAYS THEREAFTER. THE MAXIMUM PT INR AND PTT WERE 2.65 AND 65 SEC. DURING THIS INTERVAL, THERE WERE NO EXOGENOUS ANTICOAGULANTS ADMINISTERED, AND THE PATIENT WAS TAKING EXCELLENT NUTRITION. IN PART BECAUSE OF THE UNCLEAR ETIOLOGY OF THE PATIENT'S COAGULAPATHY, THE ICU STAY WAS EXTENDED DURING HOSPITALIZATION. THE PATIENT WAS DISCHARGED TO HOME ON POD #18. AT RETURN TO CLINIC ON POD #65, THE PT AND PTT HAD RETURNED TO NORMAL. EVALUATION OF PLASMA WAS LOW (9.2 ACTIVITY UNITS COMPARED TO 79-133 ACTIVITY UNITS IN NORMAL PLASMA). THIS SUGGESTED THAT THE ANTI-HUMAN FACTOR V ANTIBODY MAY HAVE RESULTED IN SOME DEPLETION OF FACTOR V, OR MAY HAVE INHIBITED FACTOR V ACTIVITY. ADDITION OF EXOGENOUS HUMAN FACTOR V (HAEMETCH, INC) TO ACHIEVE NORMAL LEVELS IN SOLUTION (7 MICROGRAM/ML) RESULTED IN ONLY PARTIAL RECOVERY TO FACTOR V ACTIVITY UNITS TO 26. THIS SUGGESTS THAT THE ANTI-HUMAN FACTOR V AT LEAST PARTIALLY BLOCKED THE FUNCTION OF EXOGENOUS (AND ENDOGENOUS) FV. SUBSEQUENT ASSAYS PERFORMED ON POD #149 REVEALED THAT THE ANTI-FACTOR V IGG WAS ABSENT FROM THE PATIENT'S PLASMA AT WHICH TIME THE PT AND PTT WERE NORMAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLOSEAL MATRIX HEMOSTATIC SEALANT STERILE HEMOSTATIC SEALANT KIT LMF BAXTER HEALTHCARE CORP. NA UNK

Patients

Seq Age Sex Outcome Treatment
1 74 YR Hospitalization