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 H7493926032300

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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) clinical study.It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2017, the patient was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the mid left anterior descending artery (lad) with 85% stenosis and was 16 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with direct placement of a 3.00 x 32 mm study stent.Following post dilatation there was 0% residual stenosis and timi 3 flow.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient's troponin level was found to be elevated.The site has reported an event of mi.On the same day, the patient was hospitalized for further investigation and treatment.Electrocardiogram (ecg) revealed, sinus rhythm, marked st elevation suggesting of acute infract.Low qrs voltage in extremity leads.Per estimated date of confinement, the diagnosis of mi was based on symptoms, biomarker elevation and ecgs changes.Mild diffuse disease proximally, 90% isr of the study stent in mid portion, mild diffuse disease noted distally; 80% ostial stenosis in 1st diagonal.The 90% isr of study stent located at mid lad was treated with predilatation and placement of 3.0 x 26mm non-bsc drug eluting stent.Following post- dilatation there was 0% residual stenosis and timi 3 flow.Five days later, the event was considered resolved and the patient was discharged from the hospital.

• 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: 7465600
• MDR Text Key: 106654923
• Report Number: 2134265-2018-03543
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• 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: 04/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2017
• Device Model Number: H7493926032300
• Device Catalogue Number: 39260-3230
• Device Lot Number: 0019456350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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: 83 YR