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 H7493926028350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Method: labeling evaluation.The device was not received 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 via facility medwatch # 5077592 that stent thrombosis occurred.In (b)(6) 2017, the patient presented to emergency room (er) with st-elevation myocardial infarction (stemi) and was then admitted.The patient was sent to cardiac catheterization lab which revealed total occlusion in the mid right coronary artery (rca) with large amount of thrombus.Overlapping inflations was then performed using 2.5x15 emerge balloon catheter providing sluggish flow.Thrombectomy was performed and brisk flow returned with minimal residual defect.Subsequently, a 3.5x28mm synergy stent was deployed in the rca with good results.The procedure was completed with no patient complications.The patient did well and was discharged on acetylsalicylic acid (asa) and brilinta.In (b)(6) 2018, the patient experienced chest pain and called emergency medical services (ems).Patient takes asa and brilinta before arriving in the er with stemi.Cardiac catheterization revealed total thrombotic occlusion of the previously placed stent in the mid rca which was then treated with thrombectomy and 3.5x20 nc emerge balloon.Timi iii flow was achieved and the procedure was completed.The patient did well and was discharged on asa and prasugrel.

• 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: 7663867
• MDR Text Key: 113197117
• Report Number: 2134265-2018-05883
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840305
• UDI-Public: 08714729840305
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2018
• Device Model Number: H7493926028350
• Device Catalogue Number: 39260-2835
• Device Lot Number: 0020618609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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