FDA Adverse Event Death Summary report: N

EMERGE

MDR report key: 11517328 · Received March 18, 2021

Report

Report Number
2134265-2021-03134
Event Type
Death
Date Received
March 18, 2021
Date of Event
January 18, 2021
Report Date
March 18, 2021
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
LOX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT DISSECTION, THROMBOSIS AND PATIENT DEATH OCCURRED. AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS BEING PERFORMED. THE PATIENT WAS TAKING ASPIRIN, A BETA BLOCKER, AND WAS ON DUAL ANTIPLATELET THERAPY. ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE ADEQUATE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. IT WAS NOTED THAT AN UNKNOWN STENT WAS PREVIOUSLY IMPLANTED IN THE PROXIMAL LAD. THE STENT WAS OBSERVED TO BE WIDELY PATENT. TIGHT STENOSIS WAS NOTED IN THE FIRST DIAGONAL BRANCH (D1) ORIGIN AND LAD JUST AFTER THE LARGE SEPTAL BRANCH. PREDILATION WAS PERFORMED IN THE FIRST DIAGONAL BRANCH (D1) WITH A 2.5X15 EMERGE BALLOON CATHETER. A 2.25 X 12 SYNERGY II DRUG ELUTING STENT WAS THEN DEPLOYED. THE SECOND LESION IN THE PROXIMAL LAD WAS DILATED WITH A 2.0X15MM EMERGE BALLOON AT THE BIFURCATION. A NON-FLOW-LIMITING DISSECTION WAS NOTED AT THE TARGET LESION. A 3.00 X 24 SYNERGY II DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LAD, OVERLAPPING DISTALLY THE PREVIOUSLY PLACED LAD STENT. THE STENT COVERS THE D1 OSTIUM TO MID LAD, BUT DOES NOT COVER THE EXTENT OF THE DISSECTION THAT OCCURRED FOLLOWING DILATION. FOLLOWING STENT DEPLOYMENT, A KISSING BALLOON DILATION (MINI CRUSH TECHNIQUE) WAS PERFORMED IN THE PROXIMAL LAD FOLLOWED BY ADDITIONAL DILATION IN THE D1 LESION. THE D1 STENT WAS CRUSHED AT THE D1 OSTIUM. MEDIA FROM THE PROCEDURE INDICATES WHEN THE LAD WIRE WAS REMOVED, THERE WERE SMALL RADIOPAQUE FILLING DEFECTS CONSISTENT WITH THROMBUS IN THE REGION OF THE DISSECTION. THE D1 WIRE WAS THEN REMOVED. BOTH TARGET VESSELS WERE NOTED TO BE WIDELY PATENT WITH TIMI 3 FLOW AND THE CASE WAS CONCLUDED. THE PATIENT WAS TRANSFERRED TO A NEIGHBORING ROOM, BUT EXPERIENCED CHEST PAIN AND WAS BROUGHT BACK TO THE LAB. THROMBOTIC OCCLUSION OF THE LAD JUST AFTER THE ORIGIN WAS OBSERVED. THE LAD WAS WIRED DURING CHEST COMPRESSIONS. BALLOON DILATION IN THE PROXIMAL LAD WAS PERFORMED, BUT FAILED TO RESTORE DISTAL FLOW. THE PATIENT WAS INTUBATED AND THE LEFT CIRCUMFLEX (LCX) WAS WIRED. THE LCX WIRE WAS REMOVED AND A STENT WAS DEPLOYED IN THE MID LAD DISTAL TO THE RECENTLY PLACED STENT. TIMI 2-3 FLOW RESTORED TO DISTAL LAD, SPIRAL CONTRAST FLOW CONSISTENT WITH DISSECTION WAS OBSERVED DISTAL TO STENT; RECENTLY STENTED D1 REMAINED TOTALLY OCCLUDED. THE D1 WAS WIRED AND LAD STENTS SEQUENTIALLY DILATED. THE D1 WAS DILATED IN PROXIMAL PORTION TO RESTORE TIMI 2 FLOW. AT SOME POINT A HEART PUMP AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WERE USED. TIMI 3 RESTORED IN LAD AND D1 WITH MILD RESIDUAL HAZINESS AT CARINA OF LAD-D1 BIFURCATION. A LONG STENT WAS PLACED ACROSS PREVIOUSLY PLACED LAD STENTS IN PROXIMAL AND MIDPORTION. THE CASE CONCLUDED WITH TIMI 3 FLOW RESTORED TO LAD AND D1 BRANCH. HOWEVER, THE PATIENT HAD SEVERE LEFT VENTRICULAR DYSFUNCTION REQUIRING MECHANICAL CIRCULATORY AND VENTILATORY SUPPORT. PRIOR TO DEATH, THE PATIENT WAS BLEEDING AND IN LIVER FAILURE DUE TO CONSUMPTION COAGULOPATHY. THE TIME OF DEATH WAS NOTED TO BE IN THE EARLY HOURS OF THE NEXT DAY AND THE DOCUMENTED CAUSE OF DEATH WAS CARDIAC SHOCK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
415012 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 47 YR Death