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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 H7493941824300
Device Problems Break (1069); Material Rupture (1546); Activation Failure (3270)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/09/2022
Event Type  Injury  
Event Description
It was reported that balloon rupture, partial deployment, and shaft break occurred. The target lesion was located in the obtuse marginal branch. The 3. 00 x 24mm synergy xd stent was advanced for treatment. Upon inflation, the stent balloon ruptured leaving the stent partially deployed. When an attempt was made to remove the device, the catheter broke leaving the balloon and about 20cm of the shaft inside the patient. Wire placement was also lost. The patient was sent for emergency coronary artery bypass graft and the device portion retained in the patient was partially removed during surgery.
 
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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 Key13933217
MDR Text Key288094639
Report Number2134265-2022-03317
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941824300
Device Lot Number0028240717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2021
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: 03/28/2022 Patient Sequence Number: 1
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