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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 H7493941820250
Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems Chest Pain (1776); Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687)
Event Date 03/12/2022
Event Type  Injury  
Event Description
It was reported that removal difficulties were encountered which led to patient complications and a shaft break. The patient presented not doing well and already in cardiac shock. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified obtuse marginal (om) branch. The physician had to stent the lesion proximal to distal. The second stent, a 2. 50 x 20mm synergy xd, was deployed to an unknown pressure below rated burst pressure. Post stent deployment, the stent delivery system (sds) balloon would not deflate and was stuck in the artery. More than 10 minutes was spent trying to deflate the balloon and while the balloon remained inflated, the patient experienced chest pain and coded. Multiple stiff wires and snares were used in an attempt to pop the balloon. When these attempts were unsuccessful, the wire and sds were pulled, but both the wire and sds shaft snapped; the sds shaft broke right before the proximal markerband. The wire fragments were able to be snared but some of the sds remained inside the patient causing the om branch to occlude. Because the patient had presented for the procedure already in cardiac shock, surgery to remove the device fragment was not an option. Additional information was requested on the patient outcome.
 
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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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13999379
MDR Text Key288597322
Report Number2134265-2022-03184
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941820250
Device Lot Number0027535510
Was Device Available for Evaluation? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2021
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: 04/04/2022 Patient Sequence Number: 1
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