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

Model Number H7493919920220

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) clinical study.Same case as: 2134265-2017-02246.It was reported that the patient experienced cardiopulmonary arrest and died.On (b)(6) 2013, the subject was enrolled in the evolve ii study 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

Describe event or problem, device codes, and patient codes updated.(b)(4).

Event Description

It was further reported that adjudication indicates stent thrombosis.

• 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: 6416689
• MDR Text Key: 70310347
• Report Number: 2134265-2017-02245
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2013
• Device Model Number: H7493919920220
• Device Lot Number: 15652411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2012
• 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
• Patient Age: 69 YR