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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems ST Segment Elevation (2059); Thrombosis (2100); Ventricular Fibrillation (2130)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.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: 2134265-2017-01680.It was reported that stent thrombosis, st elevation and ventricular fibrillation occurred.The patient presented with non st-segment elevation myocardial infarction (nstemi).The target lesion was located in the right coronary artery.After pre-dilatation, a 2.75x20mm synergy¿ drug-eluting stent was deployed in the distal rca and a 2.75x22mm drug-eluting stent was deployed in the mid rca.Subsequently, a 2.75 x 12 synergy¿ drug-eluting stent was advanced to the proximal segment of the stent in the distal rca.However, after positioning the stent and dilatation was performed at 10 atmospheres, contrast appeared in the vessel.The balloon was very difficult to remove and it became stuck in the mid rca stent.Eventually, the device was removed but the stent was no longer on the balloon.Post-dilatation was then performed with a 30x30mm non compliant balloon catheter and the procedure was completed.Post operation, in the intensive care unit (icu), the patient was noted to have st-segment elevation and went into ventricular fibrillation.The patient was successfully resuscitated; however, thrombus was noted inside the medial stents.Dilatation was then performed with a 3mm non compliant balloon catheter with good results.No further patient complications were reported and the patient's status was stable.

• 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: 6402225
• MDR Text Key: 69861455
• Report Number: 2134265-2017-01842
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2017

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: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/14/2017
• 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