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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 22515291
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 02/02/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that a foreign material was present inside the device.During preparation of a 32mmx2.50mm promus elite stent, the physician noticed a long, thin, white, silvery hair-like fiber on the device.The procedure was completed with another of the same device.No patient complications were reported the device did not enter the patient's body.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the promus elite us mr 2.50 x 32 mm device was not returned for analysis.Foreign material returned attached to promus elite label.Fm (foreign material) appeared to be a clear plastic fibrous material.Dried brown substance was also observed on the plastic that was packaging the fm.No other issues were noted during analysis.
 
Event Description
It was reported that a foreign material was present inside the device.During preparation of a 32mmx2.50mm promus elite stent, the physician noticed a long, thin, white, silvery hair-like fiber on the device.The procedure was completed with another of the same device.No patient complications were reported the device did not enter the patient's body.
 
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Brand Name
PROMUS ELITE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8372300
MDR Text Key137251750
Report Number2134265-2019-01634
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2020
Device Lot Number22515291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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