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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 H7493952838400
Device Problems Bent (1059); Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 09/17/2014
Event Type  malfunction  
Event Description
It was reported that the stent was damaged and foreign material was observed.A 4.00mm x 38mm promus premier¿ stent was opened for use.During inspection prior to use, it was noted that the stent was damaged and a gelatinous like substance was observed on the stent.The device was not used.The procedure was completed using another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system was returned for analysis.A microscopic examination of the stent struts found no evidence of foreign matter.It was noted that the stent was damaged.The struts from the centre of the stent were severely distorted and were stretched distally towards the tip of the device.The stent length was measured with a calibrated ruler to be 55mm.This type of damage is consistent with the stent encountering resistance possibly during the preparation of the device.The balloon and tip sections of the device were visually and microscopically examined and no issues were noted with their profiles that could have potentially contributed to the complaint incident.The balloon was tightly wrapped and was not subjected to positive pressure.The hypotube was kinked at various locations along its length.This type of damage is consistent with excessive force being applied to the delivery system possibly during packaging for return.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 most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that the stent was damaged and foreign material was observed.A 4.00mm x 38mm promus premier¿ stent was opened for use.During inspection prior to use, it was noted that the stent was damaged and a gelatinous like substance was observed on the stent.The device was not used.The procedure was completed using another of the same device.No patient complications were reported.
 
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Brand Name
PROMUS PREMIER?
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4167643
MDR Text Key15359611
Report Number2134265-2014-06097
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/10/2016
Device Model NumberH7493952838400
Device Catalogue Number39528-3840
Device Lot Number17201785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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