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

Model Number	6532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Vascular Dissection (3160)
Date of Event	04/08/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that death occurred.The 80% stenosed, angulated, de novo target lesion was located in the tortuous and non-calcified right coronary artery (rca).The lesion was treated with direct stenting using a 20 x 3.50 promus premier drug eluting stent.Post dilatation was performed with a 15mm x 3.50mm nc quantum apex balloon catheter.The procedure was completed and the patient status was stable.However, post-procedure, the patient experienced chest pain, palpitation, back pain, cardiogenic shock, and cardiac arrest.Electrocardiogram changes were noted and acute stent thrombosis was suspected.Enoxaparin was given to the patient to treat the thrombosis.The patient expired at night post-procedure.The official cause of death was acute stent thrombosis.It was thought that a possible proximal dissection contributed to the development of the thrombosis.No autopsy was performed.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11754098
• Report Number: 2134265-2021-05371
• Device Sequence Number: 3192554
• Product Code: LOX
• UDI-Device Identifier: 08714729783398
• UDI-Public: 08714729783398
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0026126844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death