Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10618
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.
 
Event Description
It was reported that stent damage occurred.A 3.00x16mm synergy drug-eluting stent was advanced but failed to cross the lesion.The device was simply pulled out and completely removed from the patient's body.It was noted that the distal edge of the stent struts was lifted.The procedure was completed with another of same device.No patient serious injury or adverse event were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: synergy ous mr 3.00 x 16 mm stent delivery system was returned for analysis.A visual and microscopic examination of the stent found damage to the mid-section of the stent with a stent struts lifted.The undamaged crimped stent outer diameter was measured and 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 multiple hypotube kinks.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.A 3.00x16mm synergy drug-eluting stent was advanced but failed to cross the lesion.The device was simply pulled out and completely removed from the patient's body.It was noted that the distal edge of the stent struts was lifted.The procedure was completed with another of same device.No patient serious injury or adverse event were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8184699
MDR Text Key131044093
Report Number2134265-2018-64561
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/29/2019
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0022363133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Date Manufacturer Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-