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 Problem Atrial Fibrillation (1729)

Event Date 04/18/2019

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that paroxysmal atrial fibrillation occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 20mm long and a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of a 3.50mm x 24mm promus premier study stent.Post-dilatation was performed with 0% residual stenosis.On the following day, the subject was discharged on aspirin and clopidogrel.Two weeks and two days later, the subject was diagnosed with paroxysmal atrial fibrillation and was hospitalized on the same day for further evaluation and treatment.Radiofrequency ablation was performed to treat the event.Nine days later, the outcome of the event was considered resolved and the subject was discharged on clopidogrel and aspirin on the same day.

• 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: 11813590
• MDR Text Key: 250247652
• Report Number: 2134265-2021-06212
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0022597817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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; Required Intervention
• Patient Age: 65 YR