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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 10623
Event Date 09/04/2020
Event Type  malfunction  
Event Description
It was reported that stent moved on balloon occurred.Vascular access was obtained via the radial artery.The 80% stenosed, 2.5mmx38mm, eccentric, de novo target lesion with a bend of <=45 degrees was located in the mildly calcified proximal to mid right coronary artery.After the lesion was pre-dilated with 2.5x20 maverick balloon catheter, a 2.50 x 38 synergy drug-eluting stent was selected for use.During preparation of the device, it was noted that the stent had moved on the balloon but was still within the balloon area.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
 
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Brand Name
SYNERGY
Type of Device
CORONARY 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 Key10603319
MDR Text Key209169623
Report Number2134265-2020-12473
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2021
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0024204202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/04/2020
Initial Date FDA Received09/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2019
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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