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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
Lot Number 0025322137
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no information was provided. (b)(6).
 
Event Description
It was reported that balloon rupture occurred. A 4. 00 x 12mm synergy xd drug-eluting stent was advanced for treatment; however, a back flow of blood was confirmed during the initial inflation. Therefore, it was concluded that the balloon had ruptured. The device was removed and the procedure was completed with a different device. There were no patient complications reported and the patient was in good condition post-procedure.
 
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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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13697404
MDR Text Key286951436
Report Number2134265-2022-02613
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2022
Device Lot Number0025322137
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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