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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY XD EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941824300
Device Problems Break (1069); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  Injury  
Event Description
Patient came to cardiac cath lab for stent placement on 3 locations. On the 3rd stent placement, the balloon appeared to have ruptured, when trying to retrieve the catheter approximately 20 cm broke off. Cardiothoracic surgeon contacted and patient taken to surgery. Catheter and ruptured balloon was removed from the vessel. Examined by surgeon and procedural cardiologist and determined to be intact. Patient taken to cardiovascular icu for recovery and was discharged home.
 
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Brand NameSYNERGY XD EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key14218416
MDR Text Key290161804
Report Number14218416
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 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493941824300
Device Lot Number28240717
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/2022
Event Location Hospital
Date Report to Manufacturer04/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
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