MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number UNK776

Device Problem Occlusion Within Device (1423)

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

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.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#: 2134265-2017-01142.It was reported that chest pain and acute stent thrombosis occurred.The target lesion was located in the right coronary artery (rca).After the patient was given plavix and angiomax, two synergy¿ drug eluting stents (des) were successfully implanted and the procedure was completed.The patient was then given both plavix and angiomax after the procedure and was transferred to the recovery room.However an hour later, the patient experienced continued chest pain and was brought back to the cardiac catheter laboratory.It was then noted that the stents were closed and the st segment was elevated.The thrombosis was then treated with another synergy¿ des.No further complications were reported and the patient's status was fine.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6336247
• MDR Text Key: 67595655
• Report Number: 2134265-2017-01141
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• 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): Required Intervention