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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 09/18/2018

Event Type  Injury  

Event Description

(b)(4) clinical study.It was reported that vessel dissection occurred.In (b)(6) 2018, clinical status assessment indicated the patient's qualifying condition as stable angina.Prior to procedure, the patient was noted to have abnormal stress test or imaging stress test indicative of ischemia and the patient was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the mid right coronary artery (rca) with 99% stenosis and was 42mm long with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 48mm study stent followed by post-dilatation with 2.5mm x 20mm bc quantum apex balloon catheter with 0% residual stenosis.However, post deployment of the study stent, there was a grade e bail out dissection was noted in proximal rca which was treated with the placement of a 2.5 x12mm non-study stent.Post procedure, 0% residual stenosis with timi 3 flow was noted.On the next day, the patient was discharged on dual antiplatelet therapy.

• 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
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8043273
• MDR Text Key: 126291571
• Report Number: 2134265-2018-62618
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 50 YR