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 10621
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that stent foreshortening occurred.Vascular access was obtained via the femoral artery.The 75% stenosed, concentric, de novo target lesion was located in the 45mm length and 3mm width mildly tortuous and mildly calcified right coronary (rca) artery.A 3x38mm synergy drug eluting stent was advanced and deployed in distal rca.Then a 2.75 x 28 synergy drug eluting stent was advanced and deployed in the proximal rca.Around 3mm of longitudinal stent foreshortening was noticed after post dilatation of the 2.75 x 28 synergy stent.The physician used another of the same device to complete the procedure.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that stent foreshortening occurred.Vascular access was obtained via the femoral artery.The 75% stenosed, concentric, de novo target lesion was located in the 45mm length and 3mm width mildly tortuous and mildly calcified right coronary (rca) artery.A 3x38mm synergy drug eluting stent was advanced and deployed in distal rca.Then a 2.75 x 28 synergy drug eluting stent was advanced and deployed in the proximal rca.Around 3mm of longitudinal stent foreshortening was noticed after post dilatation of the 2.75 x 28 synergy stent.The physician used another of the same device to complete the procedure.No patient complications were reported and the patient status was stable.It was further reported that the physician checked the size of the stent prior to the procedure and the stent was well positioned and apposed.However, post dilatation, stent foreshortening was seen visually.The patient was in good condition and was discharged.
 
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 Key8246880
MDR Text Key133038260
Report Number2134265-2018-65059
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 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/03/2019
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0021540532
Was Device Available for Evaluation? No
Date Manufacturer Received12/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight74
-
-