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Model Number H7493919912300
Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anoxia (1711); Cardiopulmonary Arrest (1765); Death (1802); Tachycardia (2095); Thrombosis (2100); ST Segment Depression (2487)
Event Date 11/04/2016
Event Type  Death  
Manufacturer Narrative
Device is a combination product. 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 most probable root cause was unable to be determined. (b)(4).
Event Description
(b)(6). Same case as: 2134265-2017-02245. It was reported that the patient died. On (b)(6) 2013, the subject was enrolled in (b)(6) and the index procedure was performed on the same day. Target lesion #1 was located in proximal left circumflex (lcx) artery with 99% stenosis and was 16 mm long with a reference vessel diameter of 2. 25 mm. The lesion was treated with pre-dilatation and placement of a 2. 25 x 20 mm study stent. Following post-dilatation, residual stenosis was 0%. Target lesion #2 was located in distal right coronary artery (rca) with 80% stenosis and was 8. 0 mm long with a reference vessel diameter of 3. 0 mm. The lesion was treated with pre-dilatation and placement of a 3. 00 x 12. 00 mm study stent with 0% residual stenosis. The following day, the subject was discharged on dual antiplatelet therapy. On (b)(6) 2016, the subject presented to emergency department in full cardiopulmonary arrest with asystole and 'pulseless electrical activity arrest'. The subject was unresponsive. The standard advanced cardiac life support protocol was followed in the field and an airway device was placed. Magnetic resonance imaging was conducted and noted the brain was positive for diffuse anoxic brain injury, the sulci were not effaced and no intracranial hemorrhage was noted. Electroencephalogram was performed and also suspected anoxic encephalopathy. A computerized tomography (ct) head showed no cerebral edema , however there was poor gray-white differentiation and decreased attenuation in the basal ganglia. Electrocardiogram revealed sinus tachycardia with incomplete right bundle branch block and left posterior fascicular block. There was borderline r wave progression and non specific mild st depression noted. However there were no findings suggestive of an st elevated myocardial infarction. A chest x-ray revealed worsening right upper lobe opacity consistent with atelectasis. A ct pulmonary angiography was negative for pulmonary emboli. The subject also exhibited myoclonic jerks while in icu and had hypothermic protocol and post hypothermic rewarmed. The subject continued to be unresponsive and remained intubated on mechanical ventilation. Palliative care was consulted. On (b)(6) 2016 the subject had cardiopulmonary arrest and was pronounced dead. Per the death certificate, the cause of death was unknown and an autopsy was not performed.
Manufacturer Narrative
Event Description
It was further reported that adjudication indicates stent thrombosis.
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Brand NameSYNERGY¿
Manufacturer (Section D)
Manufacturer (Section G)
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
MDR Report Key6416691
MDR Text Key70310412
Report Number2134265-2017-02246
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/16/2013
Device Model NumberH7493919912300
Device Lot Number15626574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2017 Patient Sequence Number: 1