FDA Adverse Event Malfunction Summary report: N

RESOLUTE INTEGRITY RX

MDR report key: 2780956 · Received September 18, 2012

Report

Report Number
2780956
Event Type
Malfunction
Date Received
September 18, 2012
Date of Event
June 8, 2012
Report Date
September 18, 2012
Manufacturer
MEDTRONIC, INC.
Product Code
NIQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US

Narratives

Description of Event or Problem · 1

AFTER THE PATIENT HAD UNDERGONE CORONARY ANGIOGRAPHY, HE WAS GIVENANGIOMAX BOLUS AND INFUSION FOR ANTICOAGULATION. EBU (EXTRA BACK UP) 3.75 SIX-FRENCH GUIDE WAS USED. PROWATER WIRE WAS INITIALLY USED TO ADVANCE ACROSS THE LESION IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY; HOWEVER, THE SURGEON WAS UNABLE TO CROSS AND HE USED A FIELDER XT TAPER TIP WIRE AND THE LESION WAS CROSSED USING A 1.25 X 8 MM BALLOON AND SUBSEQUENTLY A 2.5 X 12 MM BALLOON. THE SURGEON CROSSED THE LESION USING A 2.75 X 18 MM RESOLUTE STENT AND STENT WAS DEPLOYED. HOWEVER, THE SURGEON AND STAFF COULD NOT LOCATE THE STENT POST-DEPLOYMENT UNDER FLUOROSCOPY. A STENT BOOST WAS DONE AND STILL COULD NOT VISUALIZE THE STENT. AT THIS POINT, INTRAVASCULAR ULTRASOUND WAS PERFORMED OF THE VESSEL AND ON IVUS ALSO THERE WAS NO EVIDENCE OF ANY STENT IN THAT OSTIAL CIRCUMFLEX LOCATION. SO SUBSEQUENTLY THE SURGEON BUDDY-WIRED THE LESION TO DEPLOY A SECOND 2.75 X 18 MM STENT; HOWEVER, COULD NOT CROSS THE LESION, EVEN WITH THE BUDDY-WIRE. THE LESION WAS AGAIN DILATED USING A 2.5 X 15 MM BALLOON. SUBSEQUENTLY, ANOTHER GRAND SLAM WIRE WAS USED IN A BUDDY FASHION AND ANOTHER 2.75 X 18 MM STENT WAS USED TO CROSS THE LESION AND DEPLOYED AT 14 ATMOSPHERES. FINAL ANGIOGRAM SHOWED EXCELLENT ANGIOGRAPHIC OUTCOME. THE PATIENT TOLERATED THE PROCEDURE WELL, NO COMPLICATIONS. HEMODYNAMICALLY STABLE THROUGHOUT. IT IS UNKNOWN WHETHER THE SUBSEQUENT STENT WAS OF THE SAME OR DIFFERENT LOT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT NIQ MEDTRONIC, INC. * 0006052911

Patients

Seq Age Sex Outcome Treatment
1 76 YR