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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925112400
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2017
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product. (b)(4). Device evaluated by mfr. : promus premier ous mr 12 x 4. 00mm stent delivery system was returned for analysis. A visual and microscopic examination of the crimped stent found stent damage. The stent appeared to have been expanded slightly expanded and it was flattened on the balloon. The balloon was reviewed and no damage was noted. The balloon wings were folded but appeared relaxed. A visual and tactile examination of the hypotube found a hypotube kink 175mm distal to the distal end of the stain relief. A visual and tactile examination of the shaft polymer extrusion found no issues. A visual and microscopic examination of the tip identified no issues. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Reportable based on additional information received on (b)(6) 2017. It was reported that shaft kink occurred. The 75% stenosed, 10x4mm target lesion was located in the mildly tortuous and severely calcified right coronary artery. A 12 x 4. 00 promus premier¿ drug-eluting stent was advanced to treat the lesion; however, the device delivery shaft was kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, it was further reported that the stent was damaged during advancement to the lesion.
 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7154198
MDR Text Key96059716
Report Number2134265-2017-12929
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P110010
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 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2018
Device Model NumberH7493925112400
Device Catalogue Number39251-1240
Device Lot Number19810416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2016
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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