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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 H7493911420220
Device Problem Occlusion Within Device (1423)
Patient Problems Syncope (1610); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Fever (1858); Myocardial Infarction (1969); Reocclusion (1985); Sepsis (2067); Tachycardia (2095); Weakness (2145); Dizziness (2194); Discomfort (2330); Chest Tightness/Pressure (2463)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative

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).

 
Event Description

(b)(4). It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred. In (b)(6) 2012, the patient presented due to silent ischemia and coronary angiography was performed. Target lesion #1 was a de novo lesion located in the distal left circumflex artery (lcx) with 60-70% stenosis and was 10mm long with a reference vessel diameter of 2. 25mm. Target lesion #1 was treated with direct placement of a 2. 25x20mm promus element¿ plus stent, with 0% residual stenosis. Target lesion #2 was a de novo lesion located in the proximal lcx with 80% stenosis and was 8mm long with a reference vessel diameter of 3mm. Target lesion # 2 was treated with direct placement of a 3. 0x12mm promus element¿ plus stent, with 0% residual stenosis. The following day, the patient was discharged on aspirin. In (b)(6) 2016, the patient presented to the hospital for a fall, near syncope and rib pain, and was hospitalized on the same day. Associated symptoms include dizziness, exertional chest pressure, shortness of breath and weakness. Rest and nitroglycerin improved symptoms and pain. Subsequently, the patient was diagnosed with non-st segment elevation myocardial infarction (nstemi) and coronary angiography was performed. The 100% isr located in distal lcx going to second obtuse marginal branch and was treated with pre-dilation and placement of a 2. 5x38mm non-bsc drug-eluting stent, with 0% residual stenosis. In addition, the discrete stenosis of 80-90% in distal left anterior descending artery (lad), was treated balloon angioplasty with residual stenosis of less than 10%. During course of hospitalization, the patient had fever. Blood culture revealed positive and enterobacter and was subsequently diagnosed with sepsis and medication was given for treatment. Three days later, the events were considered resolved and the patient was discharged on aspirin and clopidogrel.

 
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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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5704535
MDR Text Key46760404
Report Number2134265-2016-04672
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/18/2012
Device MODEL NumberH7493911420220
Device Catalogue Number39114-2022
Device LOT Number14971932
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 Received05/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2012
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: 06/07/2016 Patient Sequence Number: 1
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