MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926038350

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059)

Event Date 09/08/2017

Event Type  Injury  

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

It was reported that restenosis occurred.In (b)(6) 2016, clinical status assessment indicated the subject¿s qualifying condition as stable angina (ccs classification: 3) and the subject was referred for cardiac catheterization and the index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery with 80% stenosis and was 35 mm long with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.50 x 38 mm study stent.Following post dilatation the residual stenosis was 0%.The next day, the subject was discharged on clopidogrel.In (b)(6) 2017, the subject presented with the complaints of shortness of breath with the history of one day and was associated with mid sternal chest discomfort and general weakness.The subject had marked leukocytosis secondary to congestive heart failure.Critical care was recommended for the subject.Cardiac enzymes were found to be elevated.Subject was noted to be fluid overload with signs of pneumonia, congestive heart failure and was diagnosed with st elevated myocardial infarction (stemi) and respiratory distress.In addition subject was also diagnosed with anemia and ventricular tachycardia.Antibiotic therapy of broad spectrum cefepime and vancomycin were started for suspected aspiration pneumonia and continued to resuscitate.Upon physician¿s assessment, subject was admitted to the hospital for further treatment.Subject had bad episode of hypotension and was transferred to intensive care unit (icu) for monitoring his blood pressure closely.Cardiology was consulted and the subject was placed on heparin therapy for the possibility of acute coronary syndrome.As the subject was diagnosed with stemi and congestive heart failure, subject was referred for cardiac catheterization by the cardiologist.Nine days later, coronary angiography was performed which revealed 90% instent restenosis (isr) of the ostial portion of the study stent, 80% isr of the distal portion of the study stent, mild diffuse atherosclerosis in rest of the lad; the 1st obtuse marginal (om) branch was jailed by the stent, however the flow was patent.On the same day, in-stent restenosis of the previously placed study stent in lad was treated with the pre-dilatation and placement of 3.5 x 38 mm a non-bsc drug eluting stent.Following post-dilatation, the residual stenosis was 0% with timi 3 flow.Post treatment, subject made continued progress with continued medical therapy.Decision was made to monitor the subject as an outpatient for his ventricular tachycardia, subject was placed on iron therapy for his anemia which was thought to be multifactorial as there was no evidence of gastrointestinal bleeding during the course of hospitalization.Ten days later, the subject was discharged on routine medication.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 7060863
• MDR Text Key: 93031706
• Report Number: 2134265-2017-11555
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• 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
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2017
• Device Model Number: H7493926038350
• Device Catalogue Number: 39260-3835
• Device Lot Number: 0019528175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR