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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
Lot Number 0029491155
Device Problem Failure to Advance (2524)
Patient Problem Perforation (2001)
Event Date 08/03/2023
Event Type  Injury  
Event Description
It was reported that failure to cross the lesion which resulted to perforation was encountered.A 20 x 3.50mm promus elite mr drug eluting stent was advanced for treatment.However, it was noted that the patient had a perforation from ballooning lesion trying to get stent across.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17612904
MDR Text Key321850189
Report Number2124215-2023-42631
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2023
Device Lot Number0029491155
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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