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); Restenosis (4576)

Event Date 07/14/2021

Event Type  Injury  

Event Description

Promus premier (b)(6) registry.It was reported that angina and restenosis occurred.In (b)(6) 2019, the subject was presented with myocardial infarction and was referred for cardiac catheterization.The index procedure was performed on the same day.Target lesion 1 was located in the proximal left anterior descending (lad) artery with 90% stenosis and was 34 mm long, with a reference vessel diameter of 3.0 mm.Target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 38 mm promus premier stent system.Following this post dilatation was performed with residual stenosis as 10%.Two weeks later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment.On the following day, the subject was referred for coronary angiography which revealed 90% stenosis in mid lad which had previously placed study device was treated with drug-eluting coronary artery stenting target-vessel revascularization (tvr).Post intervention, residual stenosis was 10%.Three days later, the event was recovered and resolved and on the same day the subject was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12475359
• MDR Text Key: 271504591
• Report Number: 2134265-2021-10960
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022752536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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; Other; Required Intervention
• Patient Age: 66 YR