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 H7493926028270

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Reocclusion (1985)

Event Date 06/05/2018

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

It was reported that in-stent restenosis occurred.The patient presented with st segment elevation myocardial infarction.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 2.75 x 28 mm synergy ii drug-eluting stent was implanted in the lad.However, after the procedure, the patient was returned to the lab complaining of chest pain.Another procedure revealed that the stent has restenosed.A 3.0 x 8 mm and a 3.0 x 12 mm non-bsc balloon catheter was used to expand the stent.Optical coherence topography revealed good stent apposition and the procedure was completed.No further patient complications were reported and patient¿s status was well.

• 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: 7655247
• MDR Text Key: 112902642
• Report Number: 2134265-2018-05672
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention