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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 01/21/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned 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 2134265-2017-00814 and 2134265-2017-00823.It was reported that myocardial infarction and stent thrombosis occurred.The target lesions were located in the circumflex artery and right coronary artery (rca).Two synergy¿ drug-eluting stents were implanted in the circumflex and one synergy¿ drug-eluting stent was implanted in the rca.During the procedure, the patient was given angiomax.The procedure was completed and the patient went to recovery.However, an hour later, the patient displayed st segment elevation myocardial infarction and all three stents had thrombosed.Another synergy stent was then implanted to treat the thrombosis and the patient was discharged on plavix.There were no further patient complications 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: 6313296
• MDR Text Key: 66859787
• Report Number: 2134265-2017-00815
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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: 01/23/2017
• 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