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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911420350
Device Problem Occlusion Within Device (1423)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985)
Event Date 12/23/2016
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Complainant address: (b)(6). 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).
 
Event Description
(b)(6) clinical study. It was reported that myocardial infarction and in-stent restenosis occurred. In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition as ischemia and stable angina. Subsequently, coronary angiography and index procedure were performed. The target lesion was located in the mid left anterior descending (lad) with 90% stenosis, a length of 16 mm and a reference vessel diameter of 3. 5 mm. The lesion was treated with pre-dilatation and placement of a 3. 50 x 20 mm study stent. Following post-dilatation, residual stenosis was 0%. One day post procedure, the patient was discharged on dual antiplatelet therapy. In (b)(6) 2016, the patient developed chest pain radiating to the left arm and neck. In addition, the patient also had dyspneic symptoms and orthopnea. The following day, patient was presented to non study hospital with complaints of chest pain which got resolved early in the morning and dyspnea on exertion. Patient was hospitalized for the same. An electrocardiogram (ecg) was performed, which revealed atrial fibrillation with complete right bundle branch block. Chest x-ray was performed, which revealed an enlarged heart. Echocardiogram revealed a greatly reduced ejection fraction (ef) and mitral insufficiency. On the same day, cardiac enzymes were noted to be elevated (peak troponin: 0. 0415 ng/ml, uln: 0. 014 ng/ml). Site has reported an event of myocardial infarction (mi). Patient was treated with medication in response to the event. Six days from the onset of symptoms, an electric reconversion was performed to treat the persistent atrial fibrillation. Subsequently, coronary angiography and transesophageal echocardiography (tee) were planned to be performed in (b)(6) 2017. In (b)(6) 2017, the subject was discharged on acetyl salicylic acid. Six days later, the patient came to study hospital for the planned coronary angiography and ecg was performed, which revealed first grade av block, right bundle branch block. On the next day, coronary angiography revealed that lad had less than 30% proximal in stent restenosis including the first diagonal at the level of implanted study stent. Subsequently, tee was performed, which revealed slightly dilated left ventricle with significantly decreased systolic function. In addition, thorax x-ray was also performed which revealed substantially widened heart. Patient's medication regimen was adjusted in response to the event. It was decided to reevaluate the patient within 6 weeks at the ambulatory care. The following day, the patient was discharged to home.
 
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Brand NamePROMUS ELEMENT¿ PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
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 Key6336235
MDR Text Key67595587
Report Number2134265-2017-01157
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/13/2013
Device Model NumberH7493911420350
Device Catalogue Number39114-2035
Device Lot Number15612811
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 Received01/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2012
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: 02/16/2017 Patient Sequence Number: 1
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