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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 H7493925120220
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the mildly calcified proximal left anterior descending artery.Following pre-dilatation, a 20 x 2.25mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion after multiple attempts.The device was removed and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the mildly calcified proximal left anterior descending artery.Following pre-dilatation, a 20 x 2.25mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion after multiple attempts.The device was removed and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: stent delivery system was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within the maximum crimped stent profile measurement.A visual examination of the bumper tip showed 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 found multiple kinks along several locations of the hypotube shaft.This type of damage noted most likely occurred due to excessive forces that could have been applied on the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues with the extrusion shaft.The bicomponent bond showed no signs of damage or strain.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 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).
 
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Brand Name
PROMUS PREMIER¿
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7575233
MDR Text Key110335630
Report Number2134265-2018-05139
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2019
Device Model NumberH7493925120220
Device Catalogue Number39251-2022
Device Lot Number20385911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Date Manufacturer Received06/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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