FDA Adverse Event Injury Summary report: N

GUIDANT RX VIATRAC PERIPHERAL DILATATION CATHETER

MDR report key: 772519 · Received October 17, 2006

Report

Report Number
3004742046-2006-00428
Event Type
Injury
Date Received
October 17, 2006
Date of Event
August 18, 2006
Report Date
October 3, 2006
Manufacturer
GUIDANT ENDOVASCULAR SOLUTIONS
Product Code
DQX
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DEVICE MALFUNCTION: NONE. SYMPTOMS/ AE: ENLARGEMENT OF PRE-EXISTING STROKE; BRADYCARDIA; HYPOTENSION. TIME OF SYMPTOMS/ AE: DURING PROCEDURE. IT WAS REPORTED THAT DURING RICA STENTING PROCEDURE, THE PATIENT DEVELOPED ENLARGEMENT OF A PRE-EXISTING STROKE. THE PATIENT HAS A HISTORY OF HYPERTENSION UNTREATED FOR AT LEAST ONE YEAR AND WAS HOSPITALIZED, IN 2006, WITH DIFFICULTY WALKING, AFFECTING THE LEFT SIDE. BLOOD PRESSURES RANGED FROM 230-196 SYSTOLIC ON ADMISSION. MRI OF THE BRAIN REVEALED A RECENT INFARCT IN THE PERIVENTRICULAR REGION IN THE POSTERIOR FRONTOPARIETAL JUNCTION AND MRA REVEALED HIGH-GRADE STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY. TWO DAYS POST STROKE, HER PRE-STENTING NIHSS (DONE IN 2006) WAS 1, DUE TO LUE DRIFT, AND SHE UNDERWENT RICA STENTING THE SAME DAY. DURING POST-DILATATION BALLOON INFLATION, THE PATIENT BECAME PROFOUNDLY BRADYCARDIC AND RECOVERED WITHIN 5-10 SECONDS AFTER ATROPINE WAS GIVEN. SHE THEN BECAME HYPOTENSIVE WITH SYSTOLIC PRESSURES IN THE 60'S AND 70'S. DOPAMINE WAS GIVEN AND HER BLOOD PRESSURE RECOVERED OVER A FEW MINUTES. THE PATIENT WAS NEUROLOGICALLY ASYMPTOMATIC DURING THIS EVENT. SEVERAL MINUTES AFTER DOPAMINE ADMINISTRATION, SHE DEVELOPED LEFT-SIDED WEAKNESS. AT THAT POINT, THE ACCUNET WAS RETRIEVED AND ANGIO DEMONSTRATED IRREGULARITIES CONSISTENT WITH RICA SPASM AT THE SITE OF THE FILTER. GOOD FILING OF THE INTRACRANIAL VESSELS WAS SEEN WITHOUT FILLING DEFECTS. ON EXAMINATION AFTER ACCUNET REMOVAL, THE PATIENT WAS UNABLE TO MOVE THE LEFT SIDE. HER PROFOUND HEMIPLEGIA SUBSIDED RELATIVELY QUICKLY AND ALMOST TO PREPROCEDURE BASELINE OVER 10-15 MINUTES. TEN TO FIFTEEN MINUTES LATER, SHE BECAME WEAK AGAIN WITH APPROXIMATELY 3/5 STRENGTH IN THE LEFT ARM AND LEG. REPEAT ANGIO DEMONSTRATED THE INTRACRANIAL VESSELS WERE ENTIRELY NORMAL WITHOUT OCCLUSIONS DISTALLY. HER LEFT HEMIPARESIS WAS WORSE AT THE END OF THE PROCEDURE COMPARED TO PREPROCEDURE AND WAS ATTRIBUTED AT THE TIME TO HEMODYNAMIC FACTORS, MAINLY HYPOPERFUSION AROUND THE INFARCTED AREA SEEN ON MRI, GIVEN THAT NO DISTAL EMBOLI OR LARGE VESSEL OCCLUSIVE DISEASE WAS SEEN EXCEPT FOR MILD SPASM OF THE EXTRACRANIAL RICA. OVER THE NEXT DAY, THE PATIENT'S EXAM WAS NOTED AS BEING MUCH BETTER WHEN SHE RAN HIGHER BLOOD PRESSURES, WHICH WAS AUGMENTED WITH DOPAMINE TO KEEP ABOVE 120 SYSTOLIC. REPEAT MRI, DONE POST-PROCEDURE, SHOWED AN ACUTE INFARCT IN THE RIGHT CORONA RADIATA THAT WAS MORE PREVALENT THAN ON THE PREVIOUS MRI. SHE WAS STARTED ON LIPITOR, ASPIRIN, PLAVIX, HYDRCHLOROTHIAZIDE, AND METOPROLOL AND WAS DISCHARGED TO REHABILITATION FIVE DAYS LATER. ON DISCHARGE, SHE STILL HAD LEFT ARM AND LEG WEAKNESS, BUT HAD ABOUT 4/5 STRENGTH IN THE LEFT UPPER EXTREMITY. ADDITIONAL INFORMATION IS UNAVAILABLE. STUDY EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GUIDANT RX VIATRAC PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER DQX GUIDANT ENDOVASCULAR SOLUTIONS NA UNK

Patients

Seq Age Sex Outcome Treatment
1 75 YR RX ACCUNET, RX ACCULINK| GUIDE WIRE: 0.038 GLIDEWIRE, AMPLATZ WIRE| SHEATH: 5FR, 7FR COOK SHUTTLE