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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 H7493925124300
Device Problem Inadequacy of Device Shape and/or Size
Event Date 02/25/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Device evaluated by mfr: the stent delivery system was returned for analysis. A visual examination of the stent found damage to the first proximal stent row with stent struts lifted and stretched in a proximal direction. The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement. A visual and microscopic examination of the bumper tip found no signs of damage. 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 tactile examination of the device found no issues along the hypotube. A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion. No other issues were identified during the product analysis. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).

 
Event Description

Reportable based on analysis completed on 22mar2018. It was reported that the stent size was incorrect for the lesion. Vascular access was obtained via the femoral artery. The eccentric target lesion with a full thrombus was located in the mid to distal right coronary artery (rca). The lesion contained a bend between >45 and <90 degrees. The physician then decided to do direct stenting without thrombosuction. Subsequently, a 24mmx3. 00mm promus premier¿ stent was advanced to treat the lesion. However, upon positioning the stent, the physician felt that the size of the stent was not appropriate for the lesion. The device was removed and a 28x3mm promus premier stent was deployed. The procedure was completed. 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 - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7426799
Report Number2134265-2018-03000
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/27/2019
Device MODEL NumberH7493925124300
Device Catalogue Number39251-2430
Device LOT Number21088630
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2017
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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