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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 H7493911608300
Device Problem Occlusion Within Device (1423)
Patient Problems Angina (1710); Reocclusion (1985); Chest Tightness/Pressure (2463)
Event Date 06/08/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.   device evaluated by mfr. : the complaint 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
Same case as mdr id: 2134265-2017-12493. (b)(6). It was reported that in-stent restenosis (isr) occurred. In (b)(6) 2012, the patient was presented with a single episode of chest discomfort and strong family history of coronary artery disease. Coronary angiography and index procedure were then performed. The target lesion was a de novo lesion located in the proximal left circumflex(lcx) with 60% stenosis and was 8mm long with a reference vessel diameter of 3. 0 mm. The lesion was treated with direct placement of 3. 00x12mm promus element¿ plus stent resulting in 0% residual stenosis. Target lesion #2 was a de novo lesion located in the mid-distal lcx with 90% stenosis and was 8mm long with a reference vessel diameter of 3. 0 mm. The lesion was treated with direct placement of a 3. 00x8mm promus element¿ plus stent resulting in 0% residual stenosis. One day post procedure, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient was presented to the emergency room with unstable angina and 2 day history of intermittent chest pain. The patient developed anterior chest wall "tightness" with no radiation of symptoms and had taken nitroglycerine in response to that, which relieved his symptoms. On the same day, the patient was admitted to the hospital. Patient's troponin cardiac enzyme to be negative, which continued to trend and patient was ruled out for acute coronary syndrome. Coronary angiography was performed and revealed 80-90% proximal isr and 80% mid vessel isr of previously placed 3. 00x12mm and 3. 00x8mm promus element¿ plus stents. Six days from admission, the 80-90% proximal isr and 80% mid vessel isr of previously placed study stents were treated with reverse saphenous graft to terminal circumflex. On the same day, the 80% stenosis in mid right coronary artery (rca) and 70% stenosis in mid left anterior descending (lad) were treated by reverse saphenous vein graft to rca and left internal mammary artery to mid distal portion of the lad respectively. Five days post procedure, the patient was seen and evaluated by a cardiologist and the event was considered to be resolved. The patient was then 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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7124853
MDR Text Key95178343
Report Number2134265-2017-12494
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
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 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/24/2013
Device Model NumberH7493911608300
Device Catalogue Number39116-0830
Device Lot Number15490016
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 Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2012
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: 12/18/2017 Patient Sequence Number: 1
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