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 Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 04/28/2019

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that coronary atherosclerotic cardiopathy occurred.In (b)(6) 2019, the subject was presented with an unstable angina and was referred for cardiac catheterization.On the same day the index procedure was performed.The target lesion was located in the distal left circumflex artery (lcx) with 100% stenosis and was 23mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of a 2.75mm x 24mm promus premier stent system.Following post dilation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2019, thirteen days post index procedure, the subject presented with symptoms of coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.Coronary atherosclerotic cardiopathy was diagnosed and no other actions were taken with regards to this event.Four days later, the event was considered recovering and resolving and subject was discharged 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: 11817028
• MDR Text Key: 250361876
• Report Number: 2134265-2021-06266
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0021439014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR