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

Model Number 9305

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 05/11/2015

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that coronary atherosclerotic cardiopathy occurred.In (b)(6) 2014, the subject presented with unstable angina as well as silent ischemia and referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) with 90% stenosis and was 12mm long, with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of 3.00mmx16mm promus element stent.Following this post-dilatation was performed with 0% residual stenosis.A week later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2015, post index procedure, the subject was diagnosed with coronary atherosclerotic cardiopathy and hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Eight days later, the event was recovered/resolved and the subject was discharged on the same day.

• Brand Name: PROMUS ELEMENT
• 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: 11751134
• MDR Text Key: 248172532
• Report Number: 2134265-2021-05493
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2015
• Device Model Number: 9305
• Device Catalogue Number: 9305
• Device Lot Number: 0016543022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2013
• 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; Required Intervention
• Patient Age: 76 YR