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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Ischemia (1942); Vascular Dissection (3160)
Event Date 11/08/2021
Event Type  Injury  
Event Description
It was reported that a dissection occurred. The 90% stenosed target lesion was located in the moderately calcified ostium to mid left anterior descending artery (lad). Following predilatation with a non compliant (nc) balloon, a 4 x 24mm synergy stent was deployed at the target lesion. Following deployment, a distal edge dissection was noted proximal to the first diagonal (d1) of the lad. A 3. 50 x 16 synergy stent was advanced to cover the dissected area across d1, but could not cross the previously placed stent at the proximal artery. A 4mm nc balloon was advanced to further dilate the proximal stent. A 3. 50 x 16mm stent was advanced, but was not able to cross the lesion. The patient was noted to be symptomatic due to the dissection. Another of same size stent was then advanced, was able to cross the lesion, cover the dissection, and complete the procedure. No further patient complications were reported in relation to this event, and the patient was reported to be stable following the procedure.
 
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Brand NameSYNERGY
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 Key12961472
MDR Text Key281925048
Report Number2134265-2021-15580
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
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,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10620
Device Catalogue Number10620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/08/2021 Patient Sequence Number: 1
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