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 H7493926016300

Device Problem Occlusion Within Device (1423)

Patient Problems ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/11/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance 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

It was reported that stent thrombosis occurred.The patient presented with an inferior st-elevation myocardial infarction.The target lesion was located in the proximal right coronary artery (rca).The lesion was predilated with a 2.5 x 15 emerge¿ balloon catheter and a 3.00 x 16 synergy ii stent was implanted.No post dilatation was performed.The patient was stable and was sent to the floor at the end of the procedure.However, approximately one hour later, st elevation was noted.The patient was found to have thrombus present in the proximal rca stent.A non bsc aspiration catheter was used to treat the thrombosis, then followed by a 3.00 nc emerge¿ balloon catheter.Intravascular ultrasound was performed to obtain image.Then a 3.5x15mm emerge¿ balloon was used for post dilation and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• 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: 6375341
• MDR Text Key: 68963878
• Report Number: 2134265-2017-01594
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: (01)08714729840114(17)20170926(10)0019784635
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: H7493926016300
• Device Catalogue Number: 39260-1630
• Device Lot Number: 0019784635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• 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
• Treatment: BALLOON: 2.5X15 EMERGE (PREDILATION)
• Patient Outcome(s): Required Intervention