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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10673
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: promus elite ous mr 20 x 3. 00mm stent delivery system (sds), was returned for analysis. The product mandrel was inserted through the wire lumen. The mandrel was removed from the distal tip without issues. The following attributes were examined: stent profile: a visual and microscopic examination of the stent found struts in the mid to distal stent region lifted and pulled distally. The undamaged crimped stent od (outer diameter) was measured and was within maximum crimped stent profile measurement specifications. Balloon profile: 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. Tip profile: a visual and microscopic examination of the bumper tip found damage to the tip. Hypotube profile: a visual, microscopic and tactile examination of the hypotube found multiple inking along the hypotube. Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion. Functional testing: the device was loaded onto a 0. 014 inch sized guidewire with no resistance noted.
 
Event Description
Reportable based on device analysis completed on 27oct2021. It was reported that the promus elite ous mr 20 x 3. 00 stent balloon expandable catheter could not cross through the guide catheter. No patient complications were reported. However, device analysis revealed stent damage.
 
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Brand NamePROMUS ELITE
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12719338
MDR Text Key279038652
Report Number2134265-2021-13626
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10673
Device Catalogue Number10673
Device Lot Number0026655085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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