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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941228220
Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
During the cath lab procedure for stent placement, the stent could not be relieved to that associated lesion due to the malfunction of the stent delivery system.When removing the stent delivery system, the system became stuck inside the guiding catheter inside the patient¿s body.Eventually, when the surgeon pulled the stent and guided the catheter the stent sheared off inside of the transducer management device, which is a co-pilot to the system.There was no harm to the patient during this event but it was a device issue.
 
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Brand Name
PROMUS ELITE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11100341
MDR Text Key224527293
Report Number11100341
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH7493941228220
Device Catalogue NumberH7493941228220
Device Lot Number24893855
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2020
Event Location Hospital
Date Report to Manufacturer12/31/2020
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26280 DA
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