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 Myocardial Infarction (1969); Reocclusion (1985); Complaint, Ill-Defined (2331); Restenosis (4576)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Event Description

(b)(6) registry it was reported that acute coronary syndrome occurred. In (b)(6) 2019, 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) with 90% stenosis and was 34mm long and a reference vessel diameter of 2. 75mm. The lesion was treated with pre-dilatation and placement of a 2. 75mmx38mm promus premier drug-eluting stent. Following post dilatation was performed with 10% residual stenosis. Five days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2019, the subject presented with symptoms related to acute coronary syndrome (acs) and was hospitalized for further evaluation and treatment. The subject was diagnosed with acs and no other action was taken to treat the event. Two weeks later, the event was considered recovered/resolved and on the same day, the subject was discharged on aspirin and clopidogrel. No other information is available at this point of time.

• 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: 10858633
• MDR Text Key: 216842017
• Report Number: 2134265-2020-15989
• 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,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/04/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022645355
• 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: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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: 11/18/2020 Patient Sequence Number: 1