MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926008220

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); High Blood Pressure/ Hypertension (1908)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as 2134265-2016-03936 & 2134265-2016-03938.It was reported the patient experienced complications post procedure.Three synergy ii drug-eluting stents were implanted; a 3.00x16mm, 2.25x8.0mm and a 2.50x12mm.The patient was discharged the same day and reported feeling great the next morning.However, the afternoon after the procedure her blood pressure went up.She returned to the hospital.A stress test, ekg and 3d echo all revealed normal results.No action was taken.As the patient continued to have issues with high blood pressure, nose bleeds, fatigue, chest pain and shortness of breath, she sought a second opinion.Adjustments were made to her medication.After approximately two weeks, she did feel a little better, but is still having some of the previously noted issues.Another follow up appointment is scheduled.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5612238
• MDR Text Key: 43796216
• Report Number: 2134265-2016-03935
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2016
• Device Model Number: H7493926008220
• Device Catalogue Number: 39260-0822
• Device Lot Number: 18362833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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): Other