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.

• 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: 9304552
• MDR Text Key: 166047823
• Report Number: 2134265-2019-13643
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• 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

• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021873858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/11/2019 Patient Sequence Number: 1