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 H7493926016220

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

Patient Problems Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Complete Heart Block (2627)

Event Date 08/15/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for evaluation.A ship history was performed which indicated the batches that were shipped to this customer.A review of the manufacturing documentation found that all devices shipped from the batches 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# 2134265-2017-08798 & 2134265-2017-09176.It was reported that fourteen days after stent implantation, the patient presented with st elevated myocardial infarction (stemi), third degree heart block, thrombosis and died one day post re-intervention.The target lesion was located in the mid right coronary artery (rca).A 2.25 x 12 synergy stent and a 2.25 x 16 synergy stent were implanted in the distal rca and the physician was attempting to deliver another 2.25 x 12 synergy stent, however, difficulty advancing in the mid rca was noted.As the physician was pulling the stent back into the guide catheter, resistance was felt and as he continue to pull back he noticed the stent stayed in the ostium of the rca and the shaft continued to pull back.When the delivery system was out of the body, he realized that the distal 8 inches of the shaft were broken off, part in the artery and part in the guide catheter.A non bsc guide extension catheter was positioned into the area and was used to re-capture the broken shaft and pull it out.The dislodged stent was deployed against the wall in the right ostial artery.After this, a dissection was noted in the rca.The vessel could not be re-wired and the patient was sent to bypass surgery.The surgery went well and the patient was doing very well.Fourteen days later, the patient presented with stemi and third degree heart block.In the cath lab, it was noted that the saphenous vein graft was full of thrombus.Three non-bsc stents were placed in the saphenous vein graft and at the end of the procedure there was a timi 1 flow down the vessel.Patient was brought upstairs to her room in a "critically ill" status and died the following morning.The cause of death was acute hemorrhage.The physician does not believe the patient death is related to the synergy stents.

• 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: 6857721
• MDR Text Key: 85764109
• Report Number: 2134265-2017-09177
• 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: 08/15/2017

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: Physician
• Device Model Number: H7493926016220
• Device Catalogue Number: 39260-1622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/12/2017
• 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): Death
• Patient Age: 69 YR