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

Model Number H7493919938300

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985); Thrombosis (2100)

Event Date 02/08/2018

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr.: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id 2134265-2018-01699.(b)(6) clinical study.It was reported that myocardial infarction, stent thrombosis and target vessel revascularization occurred and the patient died.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina.Prior to procedure, the patient was found to have abnormal fractional flow reserve (ffr) indicative of ischemia and the patient was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the mid left anterior descending (lad) artery with 60% stenosis and was 32mm long with a reference vessel diameter of 3.00mm.The lesion was treated with pre-dilatation and placement of 38x3.00mm study stent.Following post-dilation, residual stenosis was 30%.One day post procedure, the patient was discharged on dual antiplatelet therapy.On (b)(6) 2015, a 2.5x16mm synergy stent was implanted in the first diagonal.In (b)(6) 2018, the patient presented to the emergency with severe chest pain and it was reported that he did not take any medicine for the pain in morning; however, he had taken asaflow maintenance medication the night before.Cedocard and 10 mg of m+ was given in the emergency, after that drop of blood pressure was noted.On the same day, the patient was hospitalized with the diagnosis of "recidive ventricle fibrillation after st-elevation myocardial infarction (stemi)".The subject was administered with 5000 u of heparin, 180 mg of brilique and 500 mg of aspegic.Coronary angiography revealed 100% stent thrombosis (st) of proximal lad at the level of the study stent and 70-90% in-stent restenosis (isr) on first diagonal branch.The thrombosis on the lad was treated with 3.00x46mm non-bsc stent.Following post-dilation, 0% residual stenosis was noted and with timi flow 3.The 90% isr on the first diagonal branch was treated with balloon angioplasty.Post-treatment, 50% residual stenosis was noted with timi flow 3.On the same day, the patient died due to recidive ventricle fibrillation after stemi.

Manufacturer Narrative

Describe event or problem updated.Bsc id: (b)(4).Tw: (b)(4).

Event Description

It was further reported that follow-up core lab angiography of mid lad on february 2018 noted absence of thrombus as well as aneurysm.However, presence of in-stent restenosis pattern 4 was noted.

• 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: 7343272
• MDR Text Key: 102569287
• Report Number: 2134265-2018-01698
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• 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: 02/16/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: H7493919938300
• Device Lot Number: 15714695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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): Death; Required Intervention
• Patient Age: 54 YR