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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 Problem Material Rupture (1546)
Patient Problem Vascular Dissection (3160)
Event Date 03/01/2022
Event Type  Injury  
Event Description
It was reported via medwatch (b)(4) that a balloon rupture and dissection occurred. The patient was transported to the hospital with chest pain and st elevation myocardial infarction. The 100% stenosed target lesion with a significant bend of 45 degrees was located in the moderately tortuous and moderately calcified left anterior descending coronary artery. After one stent was implanted, the 3. 00 x 38mm synergy xd was advanced to the target lesion. Upon initial inflation, the stent delivery system (sds) balloon would not inflate and when the balloon was deflated, there was evidence of blood in the indeflator consistent with a ruptured balloon. As the sds was being removed from the patient, a small dissection occurred which required a third stent to repair. There were no further patient complications reported. The patient condition was stable but they required continued observation in the hospital.
 
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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 Key14058331
MDR Text Key288987991
Report Number2134265-2022-04185
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
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
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 Received03/24/2022
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

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
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