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 Syncope (1610); No Code Available (3191)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: the 2nd affiliated hospital of (b)(6).Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that patient experienced syncope.In (b)(6) 2018, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 68 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of two study stents (2.50 mm x 38 mm and 3.00 mm x 38 mm).Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, 381 days post index procedure, the subject was diagnosed with syncope and was hospitalized for further evaluation on the same day.The subject was diagnosed with an imaging procedure and a stent was implanted in the middle and proximal right coronary arteries.The event was considered resolved with residual effects and the subject was discharged home on the same day.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6).

Event Description

Promus premier china registry clinical study.It was reported that patient experienced syncope.In (b)(6) 2018, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 68 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of two study stents (2.50 mm x 38 mm and 3.00 mm x 38 mm).Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, 381 days post index procedure, the subject was diagnosed with syncope and was hospitalized for further evaluation on the same day.The subject was diagnosed with an imaging procedure and a stent was implanted in the middle and proximal right coronary arteries.The event was considered resolved with residual effects and the subject was discharged home on the same day.It was further reported that in (b)(6) 2019, the subject was referred for coronary angiography which revealed an unknown percent stenosis in the mid rca extending up to distal rca (target vessel).The subject was treated with coronary artery bypass graft (cabg) surgery.Nine days later, the event was considered recovered/resolved with sequelae and the subject was discharged on the same day 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
• MDR Report Key: 9304583
• MDR Text Key: 166048419
• Report Number: 2134265-2019-13641
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021747540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR