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

Model Number 9551

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

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 08/18/2020

Event Type  Injury  

Event Description

Promus premier (b)(6) registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending (lad) artery extending up to distal lad with 100% stenosis and was 77 mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 24 mm and 3.00 mm x 28 mm study stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject presented with cardiac related symptoms and was hospitalized for further evaluation.Five days later, the subject was diagnosed with coronary heart disease.The subject was referred for coronary angiography which revealed 80% distal stenosis in lad and was treated with percutaneous transluminal coronary angiography (ptca).Post intervention, residual stenosis was 0%.On the following day, the event was considered to be recovered and resolved and on the same day, the subject was discharged.

• 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: 12094281
• MDR Text Key: 259222673
• Report Number: 2134265-2021-08318
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0022929380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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; Required Intervention
• Patient Age: 72 YR