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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9586
Device Problem Obstruction of Flow (2423)
Patient Problems Stroke/CVA (1770); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Anxiety (2328); Numbness (2415)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
Estimated based on the aware date of (b)(6) 2019.Estimated based on provided implant date of (b)(6) 2016.Device is a combination product.
 
Event Description
It was reported that stent restenosis occurred.As reported by the patient, a 24mm x 2.5mm promus premier stent was implanted in (b)(6) 2016.Since that time, the patient has not felt right.The patient experienced an increase in blood pressure despite medication and intense chest pain.The patient has also experienced eight strokes and twelve new heart attacks which has led to right-sided numbness, difficulty walking and anxiety.Per report, the implanted stent is now occluded and remains implanted in the patient with no further intervention.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8896523
MDR Text Key154406991
Report Number2134265-2019-09728
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 consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9586
Device Catalogue Number9586
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/24/2019
Initial Date FDA Received08/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
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