MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number	10274
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Stenosis (2263)
Date of Event	09/28/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that hypotension, vessel occlusion and death occurred.The patient presented with gastrointestinal bleeding and developed st-segment elevation myocardial infarction.The target lesion located in the left anterior descending artery (lad) was treated with 24 x 2.50, 20 x 3.00 and 24 x 2.50 rebel bare metal stents.Post procedure, the patient became agitated with hypotension.The patient went into pulseless electrical activity, and was coded and intubated.A non-boston scientific temporary ventricular support device was inserted.Re-catheterization showed total occlusion in the lad and percutaneous transluminal coronary angioplasty was performed.The patient continued to require cardiopulmonary resuscitation and multiple vasopressor in the intensive care unit.The patient subsequently expired.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10729485
• Report Number: 2134265-2020-14273
• Device Sequence Number: 3457450
• Product Code: MAF
• UDI-Device Identifier: 08714729843900
• UDI-Public: 08714729843900
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 04/09/2022
• Device Model Number: 10274
• Device Catalogue Number: 10274
• Device Lot Number: 0023621787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/23/2020
• 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; Other; Required Intervention
• Patient Age: 55 YR