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

Device Problem Material Integrity Problem (2978)

Patient Problem Vascular Dissection (3160)

Event Date 09/28/2018

Event Type  Injury  

Event Description

(b)(4) study.It was reported that vessel dissection occurred.In (b)(6) 2018, the subject presented with unstable angina (braunwald classification iib).Prior to procedure, the subject was found to have elevated biomarkers indicative of ischemia and the patient was referred for cardiac catheterization.The target lesion was located in the mid right coronary artery (lcx) with 80% stenosis and was 35mm long with reference vessel diameter of 3.50mm.Pre-dilatation was attempted with a 2.75 x 30mm an nc quantum apex balloon catheter, however it was unsuccessful and the device was removed.A 3.0 x 10mm non-bsc balloon was used to pre-dilate the target lesion and the 3.50 x 48mm study stent was placed.Following post-dilation with two quantum apex balloons, 3.50 x 20mm and 4.0 x 15mm, a grade d dissection was noted.The dissection was treated with placement of 4.00 x 24mm synergy non study stent.Following post-dilatation, 0% residual stenosis with timi flow 3 was noted.

Event Description

Evolve 48 clinical study it was reported that vessel dissection occurred.In (b)(6) 2018, the subject presented with unstable angina (braunwald classification iib).Prior to procedure, the subject was found to have elevated biomarkers indicative of ischemia and the patient was referred for cardiac catheterization.The target lesion was located in the mid right coronary artery (lcx) with 80% stenosis and was 35mm long with reference vessel diameter of 3.50mm.Pre-dilatation was attempted with a 2.75 x 30mm an nc quantum apex balloon catheter, however it was unsuccessful and the device was removed.A 3.0 x 10mm non-bsc balloon was used to pre-dilate the target lesion and the 3.50 x 48mm study stent was placed.Following post-dilation with two quantum apex balloons, 3.50 x 20mm and 4.0 x 15mm, a grade d dissection was noted.The dissection was treated with placement of 4.00 x 24mm synergy non study stent.Following post-dilatation, 0% residual stenosis with timi flow 3 was noted.It was further reported that in (b)(6) 2018, post-nitrate acquisition revealed aortic dissection (grade d) which was sealed with 4.0 x 24 mm synergy non study stent placed from proximal ostium to overlapping the previously placed stent distally.In target vessel, entire stent was post-dilated with 3.5 x 20 mm nc quantum apex balloon and the proximal region was post-dilated with 4.0 x 15 mm nc quantum apex balloon.In (b)(6) 2018, the patient was discharged on dual anti-platelet therapy.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 11:42 am ct.The report number is being corrected from: 2134265-2018-64290 to: 2134265-2018-62355.

• 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
• MDR Report Key: 8009999
• MDR Text Key: 125175941
• Report Number: 2134265-2018-62355
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR