MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10604
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Chest Pain (1776); ST Segment Elevation (2059); Ventricular Fibrillation (2130)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that chest pain, ventricular fibrillation, st segment elevation and stent inadequate apposition occurred.The patient with st-elevation myocardial infarction arrived via the emergency room and was found to have a 100% occluded left anterior descending artery (lad) with thrombus present at the distal end of a non-bsc stent that had been implanted years earlier, and no distal flow in the artery.Vascular access was obtained via the right femoral artery with a 6fr sheath and a 6fr q4 guide catheter was used to cannulate the left main coronary artery.The patient was anticoagulated with heparin and act of 275 that was measured prior to stent implant.The patient was given brilinta per oral administration as well at this time.The occlusion was wired and then dilated with a 2.5 x 12mm balloon catheter and flow was restored to the artery.A 2.75 x 24mm synergy drug-eluting stent was placed just distal to the previously implanted non-bsc stent.The initial angiograms appeared to show adequate overlap between these two stents and excellent flow to the distal lad.The patient was removed from the cath lab table.Within 10 minutes the patient's symptoms began to return including elevated st segments in the ekg and chest pain.The patient was placed back to the cath lab table and right radial access was obtained.The angiogram revealed that the lad was once again occluded in the same place in the artery.Upon further inspection and with intravascular ultrasound utilization, it was found that a 3mm area was missed while placing the synergy stent and that the stent was slightly under deployed.Subsequently, a 3.0x8mm synergy stent was placed to cover the gap between the two previous stents and a 3.00mm x 12mm nc emerge balloon catheter was used to post dilate the entire length of the stents in the lad.Upon reperfusion of the artery the patient did experience one episode of ventricular fibrillation, was defibrillated, and immediately returned to normal sinus rhythm.The patient was then started on aggrastat to prevent re-thrombosis and was transferred to the intensive care unit for observation.No further patient complications were reported and the patient's status was very good.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7794833
• Report Number: 2134265-2018-60202
• Device Sequence Number: 1195497
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: 08714729840220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022140274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR