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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6530
Device Problem Failure to Advance (2524)
Patient Problems Chest Pain (1776); Death (1802); Thrombosis (2100); Cardiogenic Shock (2262); Respiratory Failure (2484)
Event Date 09/04/2018
Event Type  Death  
Event Description
It was reported that the patient died. Vascular access was obtained via the right radial and femoral artery. The 90% stenosed, 22x2. 5mm, concentric and the de novo target lesion was located in the mildly calcified left anterior descending (lad) artery. A 3. 5 (6f) non-bsc guide catheter was advanced in the ostium of the left coronary artery and a non-bsc guide wire was used to cross the significant stenosis of the proximal lad segment. Pre-dilation was performed with a 2. 0 x 20mm non-bsc balloon catheter, leaving 30% residual stenosis in the lesion. A 2. 50x24mm promus element plus drug-eluting stent was advanced but failed to cross the distal part of the stenosis. The stent was pulled back into the guide catheter with intention to perform a pre-dilatation with a larger balloon size. However, imaging showed a deformed stent at left main. The stent delivery system was removed from the guide catheter and it was noted that the stent fell off the balloon. A non-bsc guidewire managed to pass through the lumen of the deformed stent, then the stent moved from the proximal segment to the lad. A 1. 20 x 15mm and a 2. 0 x 15 mm nc quantum apex balloon catheters were used for stent expansion, but the expansion was only partial. While pulling out the balloon catheter, the partially expanded deformed stent moved into the main stem and proximal segment of the left circumflex artery. Another non-bsc guidewire was advanced through the deformed stent. A 2. 5 x 8mm nc quantum apex balloon catheter was advanced but failed to cross the deformed stent. An unsuccessful attempt was made to crush the stent to the left circumflex vessel wall. A snap was not available, another laboratory was contacted to urgently deliver one (b)(6). Then, imaging indicated thrombosis in the main stem. An extra support guidewire was advanced to the apical segment of lad. Unfortunately, the sudden failure of a machine makes the further procedure impossible. After ten minutes, the patient complained of chest pain and became respiratory insufficient. Then the patient was orotracheally intubated and connected to ventilator support. The patient developed sudden cardiogenic shock therefore intensive inotropic support was given. The patient was urgently transported by ambulance to a different catheterization laboratory to get further therapeutic intervention (b)(6). However, after the unsuccessful reanimation at the emergency department of the (b)(6) hospital center, the patient died.
 
Event Description
It was reported that the patient died. Vascular access was obtained via the right radial and femoral artery. The 90% stenosed, 22x2. 5mm, concentric and the de novo target lesion was located in the mildly calcified left anterior descending (lad) artery. A 3. 5 (6f) non-bsc guide catheter was advanced in the ostium of the left coronary artery and a non-bsc guide wire was used to cross the significant stenosis of the proximal lad segment. Pre-dilation was performed with a 2. 0 x 20mm non-bsc balloon catheter, leaving 30% residual stenosis in the lesion. A 2. 50x24mm promus element plus drug-eluting stent was advanced but failed to cross the distal part of the stenosis. The stent was pulled back into the guide catheter with intention to perform a pre-dilatation with a larger balloon size. However, imaging showed a deformed stent at left main. The stent delivery system was removed from the guide catheter and it was noted that the stent fell off the balloon. A non-bsc guidewire managed to pass through the lumen of the deformed stent, then the stent moved from the proximal segment to the lad. A 1. 20 x 15mm and a 2. 0 x 15 mm nc quantum apex balloon catheters were used for stent expansion, but the expansion was only partial. While pulling out the balloon catheter, the partially expanded deformed stent moved into the main stem and proximal segment of the left circumflex artery. Another non-bsc guidewire was advanced through the deformed stent. A 2. 5 x 8mm nc quantum apex balloon catheter was advanced but failed to cross the deformed stent. An unsuccessful attempt was made to crush the stent to the left circumflex vessel wall. A snap was not available, another laboratory was contacted to urgently deliver one (clinical hospital center in(b)(6)). Then, imaging indicated thrombosis in the main stem. An extra support guidewire was advanced to the apical segment of lad. Unfortunately, the sudden failure of a machine makes the further procedure impossible. After ten minutes, the patient complained of chest pain and became respiratory insufficient. Then the patient was orotracheally intubated and connected to ventilator support. The patient developed sudden cardiogenic shock therefore intensive inotropic support was given. The patient was urgently transported by ambulance to a different catheterization laboratory to get further therapeutic intervention ((b)(6) hospital). However, after the unsuccessful reanimation at the emergency department of the (b)(6) hospital center, the patient died. It was further reported that when they took out the stent delivery system through the guiding catheter, it was noted that the stent remained in the vessel but was not expanded. The delivery system of the stent stayed alone without the stent before any expansion in the procedure. The previously reported 2. 0 x 15 mm nc quantum apex balloon catheter that was used for stent expansion was not a bsc device. It was noted that the patient was transferred to a different catheterization laboratory ((b)(6) hospital center) which took a maximum of 20 minutes. While at the emergency department at (b)(6) hospital center, they attempted to reanimate the patient for 45 minutes. The physician stated that the patients death may have been related to the stenting event (un-expansion in the vessel), no snares at that time in the hospital and the angiography tube that stopped working.
 
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Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7919299
MDR Text Key122088407
Report Number2134265-2018-61411
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/26/2021
Device Model Number6530
Device Catalogue Number6530
Device Lot Number0021916059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2018 Patient Sequence Number: 1
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