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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 9551
Device Problem Unsealed Device Packaging (1444)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that unsealed device packing was encountered.A 24 x 4.00 promus premier drug-eluting stent was selected for use.However, it was noted that the stent envelope was opened and was not sealed well.The procedure was completed with a non-boston scientific device.No patient complications nor injuries were reported.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
 
Event Description
It was reported that unsealed device packing was encountered.A 24 x 4.00 promus premier drug-eluting stent was selected for use.However, it was noted that the stent envelope was opened and was not sealed well.The procedure was completed with a non-bsc device.No patient complications nor injuries were reported.It was further reported that when the device was opened, it was noted that the seal on the left side on the back of the packaging was affected.
 
Event Description
It was reported that unsealed device packing was encountered.A 24 x 4.00 promus premier drug-eluting stent was selected for use.However, it was noted that the stent envelope was opened and was not sealed well.The procedure was completed with a non-bsc device.No patient complications nor injuries were reported.
 
Manufacturer Narrative
(e1) initial reporter facility name: (b)(6).Device evaluated by mfr.: promus premier ous mr 24 x 4.00mm stent delivery system was returned for analysis.The device was returned inside its hoop in its opened tyvek and foil pouches and within an open carton.No damage was noted on the open device carton.No damage was noted on the open foil pouch.The tyvek pouch was found to be open fully across the peelable seal.An area of marking and discolouration was noted on the left-hand side of the horizontal seal of the tyvek pouch.The device was found to be coiled inside its hoop with its stent protector and product mandrel removed.A visual examination of the stent identified issues.There were signs of damage with proximal struts lifted and pulled distally.The crimped stent outer diameter was measured using a snap gauge 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 no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified a mid-shaft kink at 27.5 cm proximal to the distal tip.There was also evidence on device preparation as contrast media was present in the inflation lumen of the device.
 
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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 Key11155557
MDR Text Key226313463
Report Number2134265-2021-00041
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,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2022
Device Model Number9551
Device Catalogue Number9551
Device Lot Number0025605283
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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