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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9315
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the package of the device was contaminated.A 2.50x38mm promus element long drug-eluting stent was selected for use.However, during unpacking it was noted that the package of the device was contaminated.The procedure was competed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the package of the device was contaminated.A 2.50x38mm promus element long drug-eluting stent was selected for use.However, during unpacking it was noted that the package of the device was contaminated.The procedure was competed with another of the same device.No patient complications were reported and the patient's status was stable.Device evaluated by mfr.: the device was returned with an opened outer box, foil pouch and hoop.No tyvek pouch, product mandrel or stent protector were returned.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured within maximum crimped stent profile measurement.The tip was visually and microscopically examined and damage was noted.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.Hardened medium was noted in the inner lumen.No other issues were identified during the product analysis.
 
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Brand Name
PROMUS ELEMENT LONG
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7965773
MDR Text Key123803645
Report Number2134265-2018-61926
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/30/2019
Device Model Number9315
Device Catalogue Number9315
Device Lot Number0022100457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Initial Date Manufacturer Received 09/20/2018
Initial Date FDA Received10/15/2018
Supplement Dates Manufacturer Received11/06/2018
Supplement Dates FDA Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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