Summary of MedSun Reports Describing Adverse Events With Vascular Hemostasis Devices
MedSun: Newsletter #38, July 2009

Vascular hemostasis devices are used to stop bleeding from a blood vessel, usually after a medical procedure has opened an artery. During cardiac catheterization, balloon angioplasty or catheter-based procedures, the physician often will obtain access for the procedure through the femoral artery in the patient’s groin. The physician may also use the arteries in the arm, such as the radial or brachial artery. There are several types of hemostatic devices. Some administer an agent that speeds the body’s natural clotting process and stops the bleeding, while others involve a stitch in the femoral artery to close the incision site and stop the bleeding. [1]

Over the past year, MedSun has received 28 adverse event reports associated with vascular hemostasis devices [2]. The reports represent four manufacturers: 12 from Abbott Vascular, 9 from St. Jude Medical, Inc., 6 from AccessClosure, Inc., and 1 from Cardiva Medical Inc. The reports were submitted by 15 hospitals between June 5, 2008 and June 5, 2009. The reported device problems included:

• General Device Failure (8)
• Failure to deploy or improper deployment (4)
• Device did not hold (2)
• Sheath would not split (2)
• Suture material missing (2)
• Balloon burst (1)
• Device lodged in vessel (1)
• Tip broke off (1)

During this time period there were no reported deaths associated with these devices. The patient injuries listed below were reported in 15 of these 28 reports. Injuries reported include:

• Hematoma (7)
• Bleeding (4)
• Surgery (4)

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 30 patient ages were listed as greater than 21 years. Of the reports that listed patient gender, a total of 15 female patients and a total of 13 male patients were involved. Reports may have involved more that one patient.

These MedSun reports contributed to FDA awareness of the device problems. The following recall, describing problems with failure of hemostasis are noted to be associated with the StarClose device manufactured by Abbott Vascular. Reported events involving specific StarClose devices may, or may not, be involved in the recall listed.

Recall # Z-0575-2007
A recall was initiated on January 31, 2007 by Abbott Vascular Inc. for the
StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677, Lot Numbers starting from 43034-6H to 47139-6H
The reason for the recall was premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis. Recall online available,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=50232

Other FDA Articles and Notices of interest discussing Vascular Hemostatis Devices authored by FDA staff.

FDA Patient Safety News
Complications Related to the Use of Vascular Hemostasis Devices, online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=97

Medical Device Safety Alert
Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use - Phase II, online available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070057.htm







Vascular Hemostasis Devices
Device Device Identifiers Event Description
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 681696HAfter an arteriogram, a StarClose device was used to close the artery (common femoral artery left), the device failed and tore a larger hole in the artery. The artery was repaired with suture.
Abbott Vascular Devices/ StarClose No Device IdentifiersA StarClose device was being used on patient post cardiac cath procedure. When the patient got up to ambulate, the device did not hold and the patient had slight bleeding. A pressure device was applied and the patient was put on bedrest for 4 hours. Patient was discharged in a normal timeframe. The patient did not develop any other issues.
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 642096HThe physician was attempting to deploy a vascular occlusion clip when the vascular closure system failed to deploy correctly. The end of the closure system wand twisted 90% and became lodged in the vein. The physician successfully removed the device and performed the procedure successfully with an additional closure system. Manufacturer requested that we return device to them for analysis. Manufacturer is to provide a written report.
Abbott Vascular Devices/ StarClose Lot # 682696HFollowing a closure of an aneurysm in the leg with a covered stent, an attempt was made to close the access in the left groin. StarClose was attempted by the Dr. without success. Pressure was held until hemostasis was obtained.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/Lot # 60026-6HThe Perclose device did not fire. A new device was opened and also did not fire. The patient developed a hematoma which required pressure for 20 minutes prior to discharge from the OR to the PACU.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/ Lot # 690436HThe device did not contain suture.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/ Lot # 690066HTwo Perclose vascular closure devices failed to deploy the appropriate stitch in the artery. The vessel was subsequently closed with a device by a different manufacturer. There was no patient harm. The devices were saved but only one packaging was saved.
Abbott Vascular Devices/ StarClose Lot # 670046H Procedure: Angiogram: Iliac/PTA/Stent. The patient's left common femoral artery was accessed for an AP aortogram and angiogram and a StarClose device was used for closure. There was some type of misfiring of the StarClose device which did not allow it to release. The physician then made an incision in the left groin to manually remove the StarClose device and then held pressure manually over the femoral artery for 15 minutes. A hemostatic agent was placed and the incision was sewn shut. The patient tolerated the procedures well.
Abbott Vascular Devices/ StarClose Lot # 720476H A 6F StarClose was flushed and prepped. A guide wire was advanced and the sheath was exchanged for a StarClose sheath. The guidewire and dilator were pulled out and the StarClose was inserted. The top button was clicked down and the trigger was advanced splitting the sheath, but the clip on the StarClose was not deploying. The Dr. tried several times to get the device to deploy. The system was abandoned and manual pressure was held until hemostasis.
Abbott Vascular Devices/ StarClose Lot # 740266H After the sheath was changed to a StarClose sheath, the device was inserted through sheath. It was properly snapped to sheath and raised up to begin splitting, but splitting did not work. It was then noticed that a leaflet on the end of StarClose was kinked and would not advance any further. After several attempts at pulling out the system with no success, the emergency release button was used and the StarClose was aborted. Manufacturer response: the device will be replaced
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 700636HA left femoral arteriogram was completed. The StarClose was used on left groin but failed requiring compression and application of a pressure device. Patient was not injured.
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot# 720676H During an arteriogram the vascular closure device malfunctioned. The sheath didn't split completely and the StarClose device did not deploy. The patient was not injured.
AccessClosure, Inc. / MYNX Lot # F0808102 The patient developed a hematoma about the size of egg after a MYNX closure device was used to close vessel status post procedure. Manual pressure and another brand of closure device were applied. The patient was discharged but was re-admitted 5 days later for fever in the right groin.
AccessClosure, Inc. / MYNX No Device Identifiers A MYNX device was applied to the right groin but device failed. The patient developed a hematoma, and was hypotensive in the Cath Lab. Dopamine was started and another type of wound closure device was applied. The patient was transferred to CCU for observation. The patient became hemodynamically stable and the hematoma resolved. The patient was discharged home.
AccessClosure, Inc. / MYNX Lot # F0827308 When the closure device was deployed, the balloon tip for the device broke off.
AccessClosure, Inc. / MYNX No Device Identifiers A MYNX closure device was deployed in the right femoral artery. Bleeding was noted at site and manual pressure was applied by the physician. Venous sheath was also disconnected at this time per the physician's order, with pressure to the venous site. The site continued to ooze blood. A pressure device was applied approximately 15 minutes later, per the physician's order. Hemostasis was obtained with the pressure device.
AccessClosure, Inc. / MYNX Lot # F0823304 Unsuccessful closure with the device. A MYNX balloon burst while pulling back on device through sheath. It is thought to be device malfunction and not operator error.
AccessClosure, Inc. / MYNX Lot # F0824904 As the physician was attempting to deploy the MYNX device, the balloon expanded but the physician was unable to withdraw the catheter to expose the sealant. After the MYNX was passed off the sterile field, the physician attempted to pull the catheter up, but was unable to do so. Blood loss during the procedure was within normal limits (50-100cc) and a total of 50 cc of radiopaque was used during the procedure. The patient had a palpable popliteal pulse on the right side post procedure and was transported to recovery in stable condition. The physician stated one of every two MYNX devices used is defective.
Cardiva Medical Inc. / Boomerang No Device Identifiers A boomerang device was disengaged but operator unable to retrieve boomerang device. Manual pressure was held and the Dr. was notified. Manual pressure was held until finally the Boomerang device came out. Manual pressure was continued. No injury to patient was noted. The Boomerang device was noted to have a bend in the wire when it was retrieved.
St. Jude Cardiology/ Angio-Seal Evolution Catalog # C610134 Radiology tech was placing Angio-Seal, post Cardiac Catheterization. Post placement of Angio-Seal, a wire was retained. This retained wire was identified while patient was undergoing a stent placement one month later. Intact wire was removed without incident or damage to patient.
St. Jude Cardiology/ Angio-Seal No Device Identifiers This report covers four incidences in which the patient's experienced hematomas. The incidences were within a two week period.
St. Jude Cardiology/ Angio-Seal No Device IdentifiersPatient had a cath and the next day was sitting in bed and felt something pop in the right groin. The patient felt need to go to the bathroom, got up, felt weak, and fell to the floor. The patient was discovered to have a massive bleed with a retroperitoneal hematoma. The patient was taken emergently to surgery and was found to have bled from iliac artery. The surgeon indicated that the Angio-Seal had failed.
St. Jude Cardiology/ Angio-Seal Catalog # 610130 / Lot # 2076405The patient underwent a cardiac cath through a right groin approach. Three weeks later the patient was noted to have decreased pulses in the right leg and was sent back to hospital for evaluation. Angiogram on this day revealed a large 90% flap obstruction of the common femoral artery. It was felt to be hostile and unstable and possibly could cause an acute vascular compromise down the right leg. Urgent surgery was performed. The flap was removed. At the end of the surgery, the patient had a palpable pulse. The pathology report states the mass that was removed was fibrin and blood.
St. Jude Cardiology/ Angio-Seal No Device Identifiers A right groin hematoma developed less than 18 hours after cardiac catheterization resulting in delayed discharge and patient discomfort.
St. Jude Cardiology/ Angio-Seal VIP Catalog # 610310Vessel occlusion at the access site occurred during the cath lab visit. An Angio-Seal device was used as a closure device. The device was inserted per protocol but it malfunctioned. Upon attempting to cinch down collagen plug, the piece used to cinch the collagen plug was not able to be withdrawn. It appeared that the collagen plug was intra-arterial. An initial femoral angiogram revealed arterial occlusion. Subsequently vascular surgery was called emergently. The plug was able to be withdrawn but still remained intra-arterial; flow was restored to the femoral artery. The patient was taken emergently for a cut down and removal of the plug. This was done without immediate complication.
St. Jude Cardiology/ Angio-Seal No Device IdentifiersBleeding occurred after a percutaneous intervention with an Angio-Seal closure device. Manual pressure was held for fifteen minutes, and hemostasis was achieved.
St. Jude Cardiology/ Angio-Seal Catalog # 610310/ Lot # 2023627 The device was removed from the package and assembled; the dilator was inserted into the sheath. The physician removed the arterial access sheath over a guidewire. The Angio-Seal device was inserted into the artery over the existing guidewire as per standard operating procedure. The physician prepared the device to be deployed and noticed that the suture material was missing from the device. He abandoned the deployment, removed the device and applied manual pressure to the groin to obtain hemostasis. Hemostasis was successfully obtained with no sign of hematoma. The manufacturer was notified. Manufacturer representative came on site and re-inserviced staff and physicians on proper use and handling
St. Jude Cardiology/ Angio-Seal Catalog # 610310/ Lot # 2657479 A 6fr Angio-Seal was deployed per MD for vascular closure. The device did not deploy properly causing a tear/dissection of the left femoral artery. The patient was taken to OR for repair.


FDA is currently looking into the other listed device problems.

[Note: The reports have been edited for clarity]

Additional Information:

[1] Tavris, D., Dey, S. & Albrecht-Gallauresi, B. (2005). Risk of local adverse events following cardiac catheterization by hemostasis device use — phase II. Journal of Invasive Cardiology,17 (2).
http://www.invasivecardiology.com/article/4937

[2] FDA MedSun Database
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127686.htm

FDA Recall Notice. Class 2 Recall: StarClose. January 31, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=50232

Preventing Serious Injuries from Hemostasis Devices. FDA Patient Safety News. April 2002.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=97

Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use - Phase II. FDA Medical Device Safety.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070057.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun