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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 H7493911412300
Device Problem Occlusion Within Device (1423)
Patient Problems Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); Dizziness (2194); Discomfort (2330); Sweating (2444)
Event Date 01/17/2016
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) clinical study. It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred. In (b)(6) 2013, the patient presented due to stable angina and was referred for cardiac catheterization. Target lesion # 1 was a de novo lesion located in proximal left anterior descending (lad) artery with 80% stenosis and was 8. 0mm long with a reference vessel diameter of 3. 00mm. Target lesion # 1 was treated with direct placement using a 3. 00x12mm promus element plus drug-eluting stent, with 0% residual stenosis. The following day, the patient was discharged on aspirin. In (b)(6) 2016, the patient presented emergently due to nausea, sweating, dizziness and chest discomfort. Electrocardiogram (ecg) was performed which revealed st elevation in v1-3 and normal sinus rhythm. Cardiac enzymes levels were noted to be elevated and the site reported an event of non q wave mi and the patient was referred for left cardiac catheterization. The 60-80% stenosis located in proximal to mid lad was treated with direct stent placement using a 3. 00mm x 26. 00mm non-bsc stent, with 0% residual stenosis. Additionally, balloon angioplasty was performed in ostium of 1st diagonal branch, with excellent results. On the same day, the mi was considered resolved. Two days later, the patient was discharged on aspirin.

 
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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 Key5438385
MDR Text Key38247284
Report Number2134265-2016-00548
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 01/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/13/2014
Device MODEL NumberH7493911412300
Device Catalogue Number39114-1230
Device LOT Number15879862
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 Received01/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/25/2013
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: 02/16/2016 Patient Sequence Number: 1
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