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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 H7493941838300
Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Rupture (1546)
Event Date 03/01/2022
Event Type  Injury  
Event Description
It was reported that balloon rupture occurred and removal difficulties were encountered. A 3. 00 x 38mm synergy xd drug-eluting stent was advanced for treatment. However, as the stent was being deployed, the balloon burst and pulled blood into the inflation device. The physician noticed that the proximal and distal edges of stent expanded but the rest did not. The stent could not be removed or inflated. The hub was cut and a guidezilla2 guide extension catheter was introduced to successfully recapture the stent. The procedure was completed with another of same device. No patient complications were 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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13766602
MDR Text Key287196315
Report Number2134265-2022-02809
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
Reporter Occupation
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941838300
Device Lot Number0027548932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
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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