Model Number H7493926008400 |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Ventricular Fibrillation (2130); Vomiting (2144); Cardiogenic Shock (2262); Respiratory Failure (2484); Complete Heart Block (2627)
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Event Date 02/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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Same case as mdr id: 2134265-2016-01694, 2134265-2016-01695, and 2134265-2016-02196.It was reported that stent thrombosis occurred.The target lesion was located in the right coronary artery (rca).An optical coherence tomography (oct) guiding catheter was used to deploy four synergy ii drug-eluting stents sized 4.00 x 20, 4.00 x 28, 4.00 x 24, and 4.00 x 8.The procedure was completed with very good results.The patient was sent to the intensive care unit (icu) and within an hour and a half, the patient went into ventricular fibrillation, developed cardiogenic shock and respiratory failure, and was subsequently sent back to the catheter laboratory.It was noted that the implanted synergy stents had clotted off.A non-bsc extraction catheter and angiojet thrombectomy catheter were then advanced to extract the clot, and a temporary pacer and a non-bsc ventricular assistive device was placed for support.The procedure was completed with no further patient complications reported, but the patient's status was critical post procedure.The patient remains hospitalized and in stable status with chronic kidney injury.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the patient presented to the emergency room with a 6 day history of left sided upper chest pain with worsening in frequency and intensity, diagnosed as unstable angina.The index procedure was performed on the same day the patient presented to the emergency room.During the index procedure, prior to stent placement, two passes of aspirational thrombectomy with a non-bsc catheter were performed, yielding a small amount of dark red thrombus.The mid and distal right coronary artery was treated with multiple inflations from 3 different non-bsc balloon catheters.After initial angioplasty, the mid and distal rca are diffusely diseased with long areas of 70-80% stenosis in the mid vessel and focal 70-80% in the distal vessel.The stent balloons were used to perform post dilatation of the stents and the overlap zones in multiple inflations p to 16 atms.The physician was unable to pass longer stents due to the tortuosity, so multiple short stents had to be used.There was evidence of st elevation with no reflow distally after opening the artery.This was treated with intracoronary nitroglycerin.At the time of the event, the patient vomited and received acls, defibrillation and intubation at bedside.The patient was in complete heart block and receiving dopamine an dobutamine upon arrival to the cath lab.The aspiration thrombectomy catheters removed a large amount of red and while thrombus, even more than removed earlier in the day.A small amount of residual thrombus was left in the distal rca.
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Search Alerts/Recalls
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