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 Chest Pain (1776); Heart Failure (2206)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that chest pain occurred.In (b)(6) 2018, the patient presented with myocardial infarction and was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) with 100% stenosis and was 20 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 24 x 3.50 mm promus premier drug-eluting stent.Following this intervention, post dilatation was performed with 0% residual stenosis.Four days post procedure, the patient presented with paroxysmal chest pain.The event was treated medically.The following day, the event was considered recovered/resolved.Seven days later, the patient was discharged on aspirin and other antiplatelet medication.

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier china registry clinical study.It was reported that chest pain occurred.In (b)(6) 2018, the patient presented with myocardial infarction and was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) with 100% stenosis and was 20 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 24 x 3.50mm promus premier drug-eluting stent.Following this intervention, post dilatation was performed with 0% residual stenosis.Four days post procedure, the patient presented with paroxysmal chest pain.The event was treated medically.The following day, the event was considered recovered/resolved.Seven days later, the patient was discharged on aspirin and other antiplatelet medication.It was further reported that in (b)(6) 2018, the patient was diagnosed with acute heart failure.

• 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: 7785746
• MDR Text Key: 117190978
• Report Number: 2134265-2018-60034
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• 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: 10/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0021373487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR