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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
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device is a combination product.
 
Event Description
Reportable based on analysis completed on 10-dec-2018. It was reported that crossing difficulties were encountered. The target lesion was located in a coronary vessel. A 2. 75x38mm synergy stent was advanced but failed to cross the lesion. The device was removed and the procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube detachment. Synergy ous mr 2. 75 x 38 mm stent delivery system was returned for analysis. A visual examination of the stent found no issues. There was no sign of damage, stretching or lifting of the stent struts. The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands. The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement. The balloon cones were reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and microscopic examination of the bumper tip showed no signs of damage. A visual and tactile examination of the hypotube found a hypotube break 175 mm distal from the distal end of the strain relief. Multiple hypotube kinks were also noted during analysis. This type of damage is consistent with excessive force that could have been applied on the delivery system. A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.
 
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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 IRELAND LIMITED
ballybrit business park
,
galway
EI
Manufacturer Contact
sonali arangil arangil
two scimed place
,
maple grove, MN 55311
6515827403
MDR Report Key8203979
MDR Text Key131644613
Report Number2134265-2018-64681
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/13/2019
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0021559675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2017
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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