MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9554

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

Patient Problems Angina (1710); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 04/01/2021

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that coronary artery bypass grafting was performed.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed.Target lesion 1 was located in the proximal right coronary artery (rca) extending into mid rca with 100% stenosis and was 70mm long with a reference vessel diameter of 3.5 mm.Target lesion was treated with pre-dilatation and placement of 3.5 mm x 38 mm promus premier stent system stent.Post-dilatation was performed with 0% residual stenosis.On the following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, post index procedure, the subject was diagnosed with unknown type of coronary artery disease.The subject was hospitalized on the same day.The event was treated with coronary artery bypass grafting.At the time of reporting, the outcome of the event was unknown.

Manufacturer Narrative

B5.Describe event or problem- updated.

Event Description

Promus premier china registry.It was reported that coronary artery bypass grafting was performed.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Target lesion was located in the proximal right coronary artery (rca) extending into mid rca with 100% stenosis and was 70mm long with a reference vessel diameter of 3.5mm.Target lesion was treated with pre-dilatation and placement of 3.5mm x 38mm promus premier stent.Post-dilatation was performed with 0% residual stenosis.One day post procedure, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with unknown type of coronary artery disease and the subject was hospitalized on the same day.The event was treated with coronary artery bypass grafting.At the time of reporting, the outcome of the event was unknown.It was further reported that in (b)(6) 2021, the subject was diagnosed with unstable angina.The subject was discharged.At the time of reporting, the outcome of the event was considered resolved and recovered.Additionally, the physician considered the event unlikely related to the study device.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11936807
• MDR Text Key: 254298186
• Report Number: 2134265-2021-06827
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022855947
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR