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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941824450
Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem Chest Pain (1776)
Event Date 06/03/2021
Event Type  malfunction  
Event Description
Patient with history of hypertension and new onset chest pain at rest was admitted for a cardiac catheterization with stenting.Stent with implementation but after deployment, there was difficulty retrieving the balloon system as it was locked on the guidewire of the synergy xd everolimus-eluting platinum chromium coronary stent system.Deployment balloon unraveled near guidewire exit.No known harm to patient.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11990818
MDR Text Key255993943
Report Number11990818
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981213
UDI-Public(01)08714729981213(17)221216(10)26568892
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 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH7493941824450
Device Catalogue NumberH7493941824450
Device Lot Number26568892
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2021
Event Location Hospital
Date Report to Manufacturer06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30295 DA
Patient Weight85
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