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 H7493926020270

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

Patient Problems Chest Pain (1776); Fatigue (1849); Occlusion (1984)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Complainant name: (b)(6) hosp.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) study.It was reported that restenosis occurred.In (b)(6) 2016, the patient presented with unstable angina (braunwald classification: iiib) and was referred for cardiac catheterization.The target lesion was located in the mid left anterior descending artery (lad) with 90% stenosis and was 16mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of a 2.75mm x 20mm study stent with 0% residual stenosis.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient visited the study hospital reporting intermittent palpitations, substernal chest pressure (nitroglycerin 5-6 times over last month) and was in sinus.The patient also reported increasing fatigue over the last 6 months.In (b)(6) 2017, the patient presented with chest pain and abnormal stress test.The patient was hospitalized for scheduled cardiac catheterization.Coronary angiography revealed 80% stenosis in mid lad, immediately prior to the study stent which was open.The 80% stenosis at mid lad was treated with 3.0x16mm synergy stent implanted within 5mm of the study stent.Post-dilatation the residual stenosis was 0%.The proximal lad also had revascularization.The following day, the event was considered as resolved and the subject was discharged on the same day.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7136283
• MDR Text Key: 95446325
• Report Number: 2134265-2017-12534
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

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: 05/17/2017
• Device Model Number: H7493926020270
• Device Catalogue Number: 39260-2027
• Device Lot Number: 0019297665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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: 81 YR