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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 10632
Device Problems Positioning Failure (1158); Material Rupture (1546)
Patient Problem Embolism/Embolus (4438)
Event Date 01/28/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture, stent foreshortening and embolization occurred. Vascular access was obtained via the radial artery. The 48mm in length, de novo target lesion containing <
=
45 degrees bend was located in the mildly tortuous right coronary artery (rca). A 2. 75 x 48 synergy drug-eluting stent was advanced for treatment. However, during stent deployment, the balloon ruptured not allowing the stent to open, followed by a rupture of the catheter at the level of its distal segment. The undeployed and shortened stent that was mounted on the stretched balloon blocked the level of the rca. Attempts to hang the balloon with two guides mounted like a snare, followed by attempts to pass support guides behind the stent failed, justifying the urgent need for surgery.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11337629
MDR Text Key232177420
Report Number2134265-2021-01369
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2021
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0024849175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2019
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: 02/17/2021 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: CONVEY JR4; GUIDEWIRE: PT2 0.014
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