FDA Adverse Event Death Summary report: N

STARCLOSE VASCULAR CLOSURE SYSTEM

MDR report key: 685692 · Received March 8, 2006

Report

Report Number
2953144-2006-00029
Event Type
Death
Date Received
March 8, 2006
Date of Event
February 3, 2006
Report Date
February 9, 2006
Manufacturer
ABBOTT VASCULAR INC.
Product Code
MGB
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ON 02/03/2006 , THE PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL ANGIOPLASTY AND STENT PLACEMENT OF THE CIRCUMFLEX ARTERY (OFF-LABEL USE). FLOUROSCOPY WAS NOT PERFORMED PRIOR TO THE PROCEDURE THEREFORE, THE VESSEL SIZE, LOCATION AND CONDITION IS UNK. REPORTEDLY, THE PT WAS "SUCCESSFULLY CLOSED" WITH THE STARCLOSE DEVICE. AN ANGIOGRAM WAS DONE POST PROCEDURE WHICH INDICATED "HIGH STICK, TWO (2) CENTIMETERS (CM) ABOVE THE FEMORAL HEAD." IT WAS NOTED THAT THE PT "SEEMED TO AHVE MUCH DISCOMFORT DURING DEPLOYEMTN AND POST DEPLOYMENT OF THE DEVICE." FULL COMPRESSION WAS ALSO HELD FOR AAPROXIMATELY TEN (10) MINUTES AT THIS POINT IT WAS NOTED THAT THE PT'S BLOOD PRESSURE DECREASED FROM 170/105 TO 100/60 AND WAS "SUSPECTED TO AHVE A VAGAL RESPONSE TO DEPLOYMENT AND COMPRESSION." THE PT WAS GIVEN A BOLUS OF INTRAVENOUS FLUIDS AND THE BLOOD PRESSURE WAS REPORTEDLY "STABILIZED." THE PUNCTURE SITE WAS NOTED TO BE DRY WITH "NO OOZING." THE PT WAS TAKEN TO THE "HOLDING AREA" WHEHRE SHE WAS NOTED TO BE "AWAKE BUT DROWSY" WITHOUT COMPLAINTS OF ABDOMINAL OR BACK PAIN IN 02/2006, WHILE THE PT WAS IN THE CARDIAC UNIT, THE PT'S BLOOS PRESSURE REPORTEDLY ATARTED TO SLOWLY DECREASE 10 100/58. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED A RETROPERITONEAL BLEED. IT IS UNK OF THE PT RECEIVED A BLOOD TRANSFUSION AT THIS TIME BUT IT WAS REPORTED THAT THE PT WAS STABILIZED. IN 02/2006, ANOTHER CT SCAN WAS PERFORMED WHICH REVEALED A PSEUDO ANEURYSM. THE PT WAS BROUGHT TO SURGERY FOR REPAIR OF THE PSEUDO ANEURYSM. REPORTEDLY THE PT "DID FINE AFTER SURGERY" AND WAS TRANSFERRED TO THE "UNIT" IN STABLE CONDITION." THE NEXT DAY THE PT EXPIRED AT APPROXIMATELY EIGHT (8) AM. THE ACTUAL CAUSE OF DEATH IS UNK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA 35004-6H

Patients

Seq Age Sex Outcome Treatment
1 80 YR Death| R