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

Model Number H7493926216300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Hemothorax (1896); Pleural Effusion (2010); ST Segment Elevation (2059); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: device evaluated by mfr: the complaint device was not received for analysis.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure noted within the directions for use (dfu), and/or device labeling.(b)(4).

Event Description

It was reported per literature article, "a case of early stent thrombosis with hemopneumothorax", that the patient experienced st elevation, pleural effusion, hemothorax and stent thrombosis.In (b)(6) 2016 the patient presented with st-elevation anterior myocardial infarction and was admitted to the hospital.Coronary angiogram revealed cto (complete total occlusion) in the proximal lad.Percutaneous coronary intervention (pci) was performed and thrombosis was suctioned.A 3.0x16mm synergy drug eluting stent was implanted and vascular reconstruction was obtained.Following pci chest pain was resolved.6 days later the patient experienced anterior chest pain and loss of consciousness.Pulselessness occurred.Cardiopulmonary resuscitation was performed.Heart beat recovered, pulse 120 per minute and blood pressure 56/38 mmhg.St elevation occurred and the patient¿s chest x-ray showed a left pleural effusion due to decreased permeability.Ct (computerized tomography) of the chest showed left pleural fluid.The patient experienced anterior chest pain.Coronary angiography revealed stent occlusion.Coronary flow resumed after thrombus aspiration, balloon dilation and stenting.The following day the patient¿s chest pain worsened.The patient was re-examined with chest ct which revealed mediastinal deviation due to increased pleural effusion.A thoracic drain was placed and blood was discharged.Twenty two days post pci the thoracic drain was removed as there was no pulmonary dilation and bleeding.The patient was discharged from the hospital 25 days after the pci.Per the article, the patient did not have an external injury due to a fall, therefore it was highly suspected that the cause of the hemothorax was due to compression of the breastbone.

Manufacturer Narrative

Literature citation: dejima,toru et.Al."heart¿s original case: a case of early stent thrombosis with hemopneumothorax", s39/heart/(issn:0586-4488);49(9)968-973/(2017.9).(b)(4).

Event Description

It was reported per literature article, "a case of early stent thrombosis with hemopneumothorax", that the patient experienced st elevation, pleural effusion, hemothorax and stent thrombosis.In (b)(6) 2016 the patient presented with st-elevation anterior myocardial infarction and was admitted to the hospital.Coronary angiogram revealed cto (complete total occlusion) in the proximal lad.Percutaneous coronary intervention (pci) was performed and thrombosis was suctioned.A 3.0x16mm synergy drug eluting stent was implanted and vascular reconstruction was obtained.Following pci chest pain was resolved.6 days later the patient experienced anterior chest pain and loss of consciousness.Pulselessness occurred.Cardiopulmonary resuscitation was performed.Heart beat recovered, pulse 120 per minute and blood pressure 56/38 mmhg.St elevation occurred and the patient¿s chest x-ray showed a left pleural effusion due to decreased permeability.Ct (computerized tomography) of the chest showed left pleural fluid.The patient experienced anterior chest pain.Coronary angiography revealed stent occlusion.Coronary flow resumed after thrombus aspiration, balloon dilation and stenting.The following day the patient¿s chest pain worsened.The patient was re-examined with chest ct which revealed mediastinal deviation due to increased pleural effusion.A thoracic drain was placed and blood was discharged.22 days post pci the thoracic drain was removed as there was no pulmonary dilation and bleeding.The patient was discharged from the hospital 25 days after the pci.Per the article, the patient did not have an external injury due to a fall, therefore it was highly suspected that the cause of the hemothorax was due to compression of the breastbone.

• 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: 6997074
• MDR Text Key: 90930112
• Report Number: 2134265-2017-10638
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926216300
• Device Catalogue Number: 39262-1630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Weight: 64