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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 9552
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by manufacturer: a promus premier 28 x 2. 25 mm stent delivery system was returned for analysis. A visual examination of the stent found signs of stent damage with stent struts from the proximal to mid region lifted from their crimped positions and pulled distally. The undamaged stent outer diameter was measured and the result was 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 along the length of the hypotube shaft. A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 07sep2020. It was reported crossing difficulty occurred. The 95% stenosed lesion was 28 mm in length and 2. 25 mm vessel diameter, located in the severely tortuous and severely calcified left anterior descending artery. A 28 mm x 2. 25 mm promus premier drug eluting stent was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed 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 Key10610882
MDR Text Key209350279
Report Number2134265-2020-13575
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 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9552
Device Catalogue Number9552
Device LOT Number0024078007
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2019
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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