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

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

Patient Problems Nausea (1970); Chest Tightness/Pressure (2463)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported that on the same day as a promus premier stent was implanted, the patient experienced chest tightness and nausea considered related to the device.The patient was treated medically and the event was considered resolved.

Event Description

Promus premier china clinical study.It was reported that on the same day as a promus premier stent was implanted, the patient experienced chest tightness and nausea considered related to the device.The patient was treated medically and the event was considered resolved.It was further reported that the target lesion was located in the proximal right coronary artery (rca) extending up to distal rca with 100% stenosis and was 96mm long, with a reference vessel diameter of 4mm.The lesion was treated with pre-dilatation and placement of 3.00mmx38mm, 3.5mmx38mm and 4.00mmx28mm promus premier stents.Post dilatation was performed with 0% residual stenosis.Nine days later, the patient was discharged.

Manufacturer Narrative

Device is combination product.

• 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: 8278343
• MDR Text Key: 134114261
• Report Number: 2134265-2019-00379
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR