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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925138270
Device Problem Occlusion Within Device (1423)
Patient Problems Death (1802); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 01/29/2015
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that stent thrombosis also occurred on (b)(6) 2015.
 
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that the patient experienced st elevation, stent restenosis and expired. The patient presented to the emergency room with chest pain on (b)(6) 2015 and was diagnosed with an st elevated myocardial infarction (stemi). Cardiac catheterization was initiated at 13:45 and 100% stenosis of the left anterior descending (lad) artery was noted. A 2. 75x38 mm promus premier¿ stent was implanted in the lad followed by dilation with a balloon. The surgery was considered successful and the st levels declined at 14:50. The patient continued to experience chest tightness and a ecg was performed the following day, which showed as q wave (v2-6) with st elevation. The surgeon suggested to performed additional cardiac catheterization; however the patient's family declined. The patient was transferred to another hospital. Treatment with antiplatelet drug, heparin and nitroglycerin was provided and the patient didn't feel chest tightness temporarily. St elevation was again noted and cardiac catheterization was performed, and there was 100% restenosis of the lad. A balloon was then used to place the intra-aortic balloon pump (iabp), however the patient had respiratory failure and was placed on a tracheal tube on (b)(6). On (b)(6) cardiac catheterization was performed and a 3. 0x30 mm and 3. 5x30 mm non-bsc stent were implanted resulting in timi iii flow. However iabp was again placed on (b)(6). The patient was not very stable. Patient experienced pulseless ventricular tachycardia and received electric shock at 02:40 on (b)(6), then had pulseless electrical activity at 12:14, and the patient had expired.
 
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Brand NamePROMUS PREMIER¿
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 Key6849114
MDR Text Key101312673
Report Number2134265-2017-09162
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeTW
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,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/04/2015
Device Model NumberH7493925138270
Device Catalogue Number39251-3827
Device Lot Number0017045387
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 Received09/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2014
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: 09/07/2017 Patient Sequence Number: 1
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