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 01/31/2020

Event Type  Injury  

Event Description

It was reported that dissection occurred and patient experienced chest pain.The patient presented with st-elevation myocardial infarction and the target lesion was located in the mid-right coronary artery.A 3.0x24 synergy drug-eluting stent was implanted in the lesion area.However, after the patient went for recovery, a severe chest pain was felt and was returned to cath lab.It was found that the stent was occluded and so it was wired with a choice pt extra support.A 3.0x12 nc quantum apex balloon catheter was used to re-open the artery, followed by an angiojet catheter to removed the clot from the stent and used ivus to interrogate it.A small dissection was noted in the proximal end of the stent and so a 3.5x8 synergy des was placed in an overlapping fashion to the initially placed stent.Both devices were post dilated with a 3.5x8 nc quantum balloon catheter.The stent was re-ivus again to confirm the apposition, expansion and treatment of the small dissection.Defibrillators were not used in this case.No further patient complications were reported.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9728803
• MDR Text Key: 180411767
• Report Number: 2134265-2020-01646
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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
• Date Manufacturer Received: 01/31/2020
• 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): Hospitalization; Required Intervention