FDA Adverse Event Injury Summary report: N

MEDTRONIC RESOLUTE STENT

MDR report key: 3982810 · Received July 24, 2014

Report

Report Number
3982810
Event Type
Injury
Date Received
July 24, 2014
Date of Event
July 8, 2014
Report Date
July 22, 2014
Manufacturer
MEDTRONIC
Product Code
NIQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2014 THIS (B)(6) MALE PT UNDERWENT A CARDIAC CATHETERIZATION VIA THE RIGHT FEMORAL. CATHETERIZATION REVEALED A LEFT MAIN WITH MEDIUM TO LARGE WITH A 40-50 PERCENT TUBULAR STENOSIS IN ITS MID SEGMENT, THE LEFT ANTERIOR DESCENDING WAS OCCLUDED AT THE ORIGIN, AND THE CIRCUMFLEX WAS PATENT AND OBTUSE MARGINAL OCCLUDED IN THE MID TO DISTAL SEGMENT. THE NATIVE RIGHT CORONARY ARTERY IS PATENT BUT HAD MULTIPLE HIGH GRADE STENOSIS. THE VEIN GRAFT TO THE OBTUSE MARGINAL WAS NOTED HAVE A HIGH GRADE 99" ECCENTRIC STENOSIS. THE LEFT INTERNAL MAMMARY ARTERY WAS WIDELY PATENT. A LEFT VENTRICULOGRAM SHOWED INFERIOR WALL HYPOKINESIS, PRESERVED LV FUNCTION AND AN EJECTION FRACTION OF 45 PERCENT CORONARY ANGIOPLASTY: PER THE PROCEDURE NOTE A 6 FRENCH SHEATH AND A LCD GUIDE WAS USED AND A WHISPER WIRE WAS PLACED IN THE VEIN GRAFT, ANGIOPLASTY WAS PERFORMED WITH A 2.5 MILLIMETER BALLOON BETWEEN EIGHT (8) - TEN (10) ATMOSPHERES ON TWO (2) OCCLUSIONS. EACH INFLATION LASTER APPROXIMATELY THIRTY (30) - FORTY FIVE (45) SECONDS. THE STENT WAS THEN INSERTED IN THE VEIN GRAFT UNFORTUNATELY THE STENT BENT IN THE SHAFT AND IT SNAPPED AND THE STENT HAD TO BE RETRIEVED WHICH WAS DONE SUCCESSFULLY WITH THE STENT ON THE BALLOON INTACT WITHOUT ANY DAMAGE TO THE VEIN GRAFT. THE ENTIRE STENT AND BALLOON WAS REMOVED AND THE NEW STENT 3.0 X 18 MILLIMETER WAS DEPLOYED AT FOURTEEN (14) ATMOSPHERES FOR FORTY FIVE (45) SECOND INFLATION, TWO (2) STENT INFLATIONS PERFORMED FOURTEEN (14) - FIFTEEN (15) ATMOSPHERES RESULTING IN 0 PERCENT RESIDUAL STENOSIS WITH BRISK AND NORMAL FLOW. THERE WAS NO EVIDENCE OF DISSECTION, THROMBUS OR DISTAL EMBOLIZATION. THE CATHETERS AND WIRES WERE REMOVED AND NOTED TO BE INTACT. THERE WAS NO BLEEDING OR HEMATOMA AT THE TIME. THE PT WAS DISCHARGED ON (B)(6) 2014.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
435147 MEDTRONIC RESOLUTE STENT RESOLUTE STENT NIQ MEDTRONIC 240RSINT30018UX 0007131776

Patients

Seq Age Sex Outcome Treatment
1 82 YR Required Intervention