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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC SYNERGY XD STENT 3.00MM X 12MM CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC SYNERGY XD STENT 3.00MM X 12MM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941812300
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
During a pci (percutaneous coronary intervention) procedure in the cardiac cath lab the stent came apart from the delivery balloon. It was a suspected supply malfunction. There was no harm to the patient as a balloon that was in place was expanded to protect the distal vessel. Then the guide was advanced to capture the stent. A second balloon was placed in the guide to trap the stent in the guide, and everything was removed as a single unit. New equipment was used to complete the procedure. Fda safety report id# (b)(4).
 
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Brand NameBOSTON SCIENTIFIC SYNERGY XD STENT 3.00MM X 12MM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key13367176
MDR Text Key284647153
Report NumberMW5107017
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941812300
Device Catalogue NumberH7493941812300
Device Lot Number28083611
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes

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