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

Model Number	H7493911416350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); Occlusion (1984)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that myocardial infarction and restenosis occurred.In (b)(6) 2013, the patient presented due to unstable angina and myocardial infarction and was referred for cardiac catheterization.Subsequently, coronary angiography was performed.Target lesion # 1 was a de novo lesion located in the distal right coronary artery (rca) with 100% stenosis and was 15mm long with a reference vessel diameter of 3.0mm and was treated with pre-dilatation and placement of a 3.00x16mm promus element¿ plus stent.Following post dilatation, with 0% residual stenosis and timi 3 flow.Target lesion #2 was a de novo lesion located in the proximal left anterior descending (lad) with 95% stenosis and was 15mm long with a reference vessel diameter of 3.5mm and was treated with pre-dilatation and placement of a 3.50x16mm promus element¿ plus stent.Following post dilatation, with 0% residual stenosis and timi 3 flow.Two days post procedure, the patient was discharged on aspirin.In (b)(6) 2017, the patient was presented to emergency department with the complaints of chest pain, chest pressure.The patient had mild shortness of breath and diaphoresis and was hospitalized on the same day.The patient's cardiac enzymes were noted to be elevated and the site as reported an event of acute st segment elevation myocardial infarction.Subsequently, the patient was referred for cardiac catheterization.The 95% stenosis located in proximal lad was treated with balloon angioplasty and placement of 3.5 x 16mm bare metal rebel stent into the proximal segment of previously deployed study stent.Post-procedure course was uncomplicated.Two days post procedure, the event was considered as resolved and the patient was discharged from the hospital in a stable condition.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7301650
• Report Number: 2134265-2018-01438
• Device Sequence Number: 11072018
• Product Code: NIQ
• UDI-Device Identifier: 08714729808015
• UDI-Public: 08714729808015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15764913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR