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 Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent dislodgment occurred and patient was sent to surgery.The target lesion was located in the left coronary artery.A 4.00 x 16 synergy drug-eluting stent was advanced or treatment.However, the stent dislodged and was successfully removed via surgery.After removal, the stent was lost outside the patient's body.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the stent delivery system was returned without the stent.There were multiple severe hypotube kinks, polymer extrusion shaft kinks, tip damage and evidence of inner lumen stretching.Procedural challenges most likely led to the reported event, as the device most likely met with a restriction within the vessel and became dislodged.The hypotube and shaft damage was most likely a result of unintentional excessive manipulation by the user.
 
Event Description
It was reported that stent dislodgment occurred and patient was sent to surgery.The target lesion was located in the left coronary artery.A 4.00 x 16 synergy drug-eluting stent was advanced or treatment.However, the stent dislodged and was successfully removed via surgery.After removal, the stent was lost outside the patient's body.No patient complications were reported and the patient's status was stable.It was further reported the lesion was predilated.
 
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 Key9530615
MDR Text Key173337640
Report Number2134265-2019-16260
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,foreig
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/26/2020
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0023272544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received02/13/2020
Supplement Dates FDA Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight60
-
-