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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 H7493941812400
Device Problems Material Rupture (1546); Activation Failure (3270)
Patient Problem Insufficient Information (4580)
Event Date 03/04/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture and inadequate or insufficient apposition occurred. The 99% stenosed, target lesion was located in a severely tortuous and severely calcified obuse marginal branch segment/ left cirmuflex artery. The vessel was prepared with multiple balloons and a guidezilla guide extension catheter was needed to facilitate balloon and stent delivery. A 4. 00x12mm synergy xd drug-eluting stent was deployed for treatment. However, during the initial inflation prior to reaching nominal pressure the balloon ruptured. It was noted that the balloon did not expand beyond the edges. The balloon was removed but the stent was severely underexpanded. After multiple attempts, 2. 0 up to 4. 0 balloons were used to fully inflate the stent and ensure adequate expansion. The patient was treated successfully with multiple stents back to the left main and the procedure was completed. No patient complications nor injuries reported.
 
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Brand NameSYNERGY XD
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11558358
MDR Text Key241931249
Report Number2134265-2021-03054
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941812400
Device Lot Number0026547433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2021 Patient Sequence Number: 1
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