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

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.

• Brand Name: NC QUANTUM APEX
• Type of Device: CATHETERS, 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 Key: 7919299
• MDR Text Key: 122088407
• Report Number: 2134265-2018-61411
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• 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 Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0021916059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 90