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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 9550
Device Problems Break (1069); Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 06/13/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product (b)(6).
 
Event Description
It was reported that stent fracture occurred.A 20x3.50mm promus premier drug eluting stent was selected for use.However, during unpacking, it was noticed that the promus premier stent appeared to be fractured.The procedure was completed with a new promus premier stent.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.(e1) initial reporter address 1: (b)(6).Device evaluated by mfr.: promus premier ous mr 20 x 3.50mm stent delivery system, catheter was returned for analysis.An examination of the crimped stent found no issues with the stent.There were no signs 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 within max crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a break 28mm distal to the distal end of the strain relief and a hypotube kink 140.8cm proximal to the distal end of the distal tip.A visual examination of the shaft polymer extrusion found no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent fracture occurred.A 20x3.50mm promus premier drug eluting stent was selected for use.However, during unpacking, it was noticed that the promus premier stent appeared to be fractured.The procedure was completed with a new promus premier stent.No patient complications were reported and the patient's status was stable.It was further reported that shaft kink and shaft break occurred when the device was removed from the casing.
 
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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 Key10267890
MDR Text Key198705919
Report Number2134265-2020-08675
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 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2021
Device Model Number9550
Device Catalogue Number9550
Device Lot Number0024637657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Date Manufacturer Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
Patient Weight75
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