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 H7493926012220

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Nausea (1970); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-07228 and 2134265-2018-07227.It was reported that patient experienced chest pain and acute thrombosis occurred.The target lesion was located in the proximal to mid left anterior descending artery (lad).A 2.75x12 synergy ii drug-eluting stent was implanted in the proximal lad.The mid lad was treated with 2.25 x 16 mm and a 2.25 x 12 mm synergy ii drug-eluting stents.The final angiogram looked great.While the patient was being removed from the table, the patient experienced nausea and chest pain.The physician had ordered the patient to be loaded with aspirin and plavix but the patient refused to take any medication.Some time later, the patient did receive aspirin and plavix.The patient continued to have chest pain and some st elevation.An echo was performed which came back clear but the patient started to show more prominent st elevation.Another angiogram was performed which revealed the stented area had stent thrombosis.The patient was loaded with an integrilin bolus and started on an integrilin drip.A second integrilin bolus was given directly ic and the stented area dilated with a 2.0x12 balloon.The patient's st elevation disappeared, the patient had no chest pain, and the thrombosis was considered resolved.An intravascular ultrasound was performed which revealed the stents were well apposed.

• 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: 7753529
• MDR Text Key: 116131376
• Report Number: 2134265-2018-07229
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2019
• Device Model Number: H7493926012220
• Device Catalogue Number: 39260-1222
• Device Lot Number: 0021614226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• 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: 87 YR