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 H7493926008300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 06/04/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id 2134265-2017-08903.It was reported that stent thrombosis occurred.Vascular access was obtained via the right radial artery.The 0.014 non-bsc guidewire angioplasty was introduced to the proximal left anterior descending (lad) artery that has 100% acute total occlusion, mostly due to what appeared to be spontaneous plaque rupture.The device able to cross the 100% total occlusion successfully and the non-bsc guidewire angioplasty was advanced distally to the first diagonal branch.Subsequently, a second wire of 0.014 non-bsc guidewire angioplasty was advanced and crossed again the proximal lad artery and advanced all the way distally into the distal lad artery.Next, percutaneous transluminal coronary angioplasty (ptca) of the proximal lad artery was performed using 2.5x12mm non-bsc balloon catheter which improved the antegrade flow and now, it is clear that there is severe diffuse disease in the early mid lad artery, in addition to the proximal total occlusion.Subsequently, balloon angioplasty of the ostial diagonal branch was performed using a 2.5 balloon catheter.This was followed by delivering 2.75x38mm synergy drug-eluting stent that was used to cover the entire mid lad artery that has severe diffuse disease and extending proximally to the proximal lad artery across the origin of this diagonal branch.Stent was deployed successfully at 12 atmospheric pressure.This was followed by delivering 3.0x8mm synergy drug-eluting stent to cover the ostial lad artery and deployed successfully at 12 atmospheric pressure for 30 seconds, reducing the initial 100% total occlusion and severe diffuse disease of the mid lad artery to less than 0% residual with normal timi-3 flow and grade 3 perfusion.The diagonal branch was jailed by the lad stent for which reason, the non-bsc guidewire angioplasty was re-direct through the struts of the stent into this diagonal branch and balloon angioplasty of the ostium through the struts was performed using 2.5x12 balloon flaring the stents and reducing the ostial stenosis to less than 10% residual with normal timi-3 flow and grade 3 perfusion and no need for stent of this diagonal branch.The patient tolerated the procedure well with no complication.Thirteen days later, the patient presented to the emergency room with severe chest pain and st-elevation.Intravascular ultrasound showed complete occlusion an thrombosis of the lad stent.Ballooning was done to open the vessel.

• 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: 6852455
• MDR Text Key: 85420775
• Report Number: 2134265-2017-08904
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: (01)08714729839996(17)20180206(10)0020267895
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: H7493926008300
• Device Catalogue Number: 39260-0830
• Device Lot Number: 0020267895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 75