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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 9549
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that shaft break occurred.A 16 x 4.00 promus premier drug-eluting stent was selected for use.However, it was noticed that shaft broke during pre-deployment in the guide catheter.No known patient complications were reported.
 
Event Description
It was reported that shaft break occurred.A 16 x 4.00 promus premier drug-eluting stent was selected for use.However, it was noticed that shaft broke during pre-deployment in the guide catheter.No known patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: promus premier ous mr 16 x 4.00 mm stent delivery system was returned for analysis.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 between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement.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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks and a break 65.2cm distal to the distal end of the strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
 
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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
MDR Report Key10304658
MDR Text Key199857768
Report Number2134265-2020-09173
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,foreig
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2021
Device Model Number9549
Device Catalogue Number9549
Device Lot Number0024703623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2020
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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