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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 9548
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter facility name: (b)(6). Device evaluated by mfr. : promus premier ous mr 12 x 2. 75 mm stent delivery system was returned for analysis. An examination (visual and via scope) of the crimped stent found stent damage. Stent struts from the mid and distal stent region were noted to be lifted from their crimped position and pulled proximally and distally. The undamaged crimped stent outer diameter was measured and the result was within max 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 tip damage. A visual and tactile examination of the hypotube shaft found multiple kinks located at different places along the length of the hypotube shaft. 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. The device was loaded without issues on a 0. 014 inch test guidewire. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 02sep2020. It was reported that advancing difficulties were encountered. The chronically occluded diffused target lesion was located in the left anterior descending artery. After a guide wire was advanced to the distal end of the lesion, pre-dilatation was performed with a 1. 2x12mm balloon catheter. There was a branch bifurcation lesion in the middle segment. A 12 x 2. 75 promus premier drug-eluting stent was advanced but could not reach the lesion and the stent was stuck. The physician retrieved the stent through the catheter. The procedure was completed with another of the same device. There were no patient complications reported and the patient's status was stable. However, returned device analysis revealed a stent damage.

 
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Brand NamePROMUS PREMIER
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 Key10594024
MDR Text Key208796311
Report Number2134265-2020-12408
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/13/2020
Device MODEL Number9548
Device Catalogue Number9548
Device LOT Number0022405861
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/14/2018
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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